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Join an innovative med?tech organization driving the development of advanced digital products used globally in healthcare. We are looking for a Senior DevOps Engineer who will own and evolve our cloud, infrastructure automation, and CI/CD capabilities—directly enabling our teams to deliver secure, scalable, and high?quality software.
Your Impact
In this role, you will design, build, and maintain automated infrastructure and deployment pipelines that support a modern software development lifecycle. You’ll collaborate closely with engineering teams, drive continuous integration practices, and champion DevOps culture across the organization.
What You Will Do

• Build and maintain scalable, secure CI/CD pipelines
• Develop and manage Infrastructure as Code using Terraform to provision and configure cloud services
• Design and operate secure Azure cloud environments
• Partner with development teams to automate workflows and strengthen continuous integration
• Embed security?enhancing steps such as code signing, static analysis, and security testing into product build processes
• Coach teams on DevOps best practices and mindset
• Mentor colleagues on architecture, tooling, and operational excellence

What You Bring

• Bachelor’s degree in computer science, software engineering, or a related technical field
• 5+ years of experience in Development or DevOps environments, including cloud administration (Azure preferred)
• Strong communication skills and the ability to collaborate across teams
• Hands?on experience with GitHub, GitHub Actions, Azure DevOps, or similar pipeline platforms
• Familiarity with automation tooling such as Jenkins, Snyk, Sonar, or New Relic
• Practical knowledge of DevOps frameworks (Ansible, Terraform, HashiCorp Packer)
• Experience with network administration and monitoring tools
• Fluency in English

]]> Tue, 10 Mar 2026 00:00:00 EDT 1 *depending on exp

Summary: Applies a solid understanding of engineering and problem-solving theories/practices toward the development of new or enhanced products or processes. Creates service deliverables and infrastructure required to support initial product launch and lifecycle management. Capable of designing machine tooling, jigs, fixtures, gauges and equipment used in the servicing process. Capable of checking designs and drawings against general standards, design requirements, geometric tolerances, drafting practices and the manufacturing process involved. The work of the individual should be highly creative, of high quality and offer wide latitude for independent judgment and perception with a minimal amount of supervision.

Essential Duties & Responsibilities:
1. Creates new product development and lifecycle management service deliverables throughout the product lifecycle for medical device products involving hardware.
2. Supports new product platform releases. Develops and implements service training, test equipment, tools, spare parts, and service manuals / instructions.
3. Evaluates / makes recommendations on product releases related to design for serviceability. Creates (or modifies existing) servicing processes and manuals to support repair or refurbishment of fielded product at multiple global sites or in the field.
4. Works closely with design team to select, develop, and implement technologies across all medical device development programs.
5. Analyzes key servicing metrics to identify and implement opportunities for improvement in service process quality, cost, or product reliability.
6. Coordinates information flow between corporate and local/regional teams.
7. Owns Corrective and Preventive Actions related to the product(s) core team(s) supported, using sound root cause analysis.
8. May represent Technical Services on new product development and/or lifecycle management core teams.
9. May independently plan, schedule and lead cross-functional teams in detailed phases of the engineering work in a project.
10. May approve the work of lower level engineers; may supervise other engineers or technicians

Minimum qualifications:
1. Must be well versed in core engineering disciplines (e.g. mechanical, electrical, software, systems engineering).
2. Highly motivated self-starter who is able to work with minimal supervision.
3. Must have good interpersonal and oral/written communication skills, good time management, and be capable of analyzing and solving technical problems through innovative thought and application of sound engineering principles and root cause analysis.
4. Experience with change control methodologies and configuration management principles is a plus.
5. Experience with test engineering and/or reliability engineering principles is a plus.
6. Ability to exercise independent judgment and draw conclusions based on available information.
7. Good understanding of GMP and quality system requirements.
8. Must have the ability to travel.

Education and/or Experience: Bachelors degree in a core engineering discipline (mechanical, electrical, software, systems, or mfg/process engineering) plus 3-5 years of experience. Medical device experience or other regulated industry experience preferred. Experience in the use of Lean Six Sigma tools highly desirable.]]> Mon, 09 Mar 2026 00:00:00 EDT 1
Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

Job Responsibilities:
1) Support automation capital project software development testing, commissioning activities etc.
2) Support day to day operations of the plant for automation related issues including on call rotation every 7-8 weeks.
3) Support Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with cross functional teams.
4) Support Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
5) Support Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and  CMDB systems.
6) Ensure compliance to Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
7) As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
8) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Preferred Qualifications:
1) Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
2) Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product plant operations.
3) Has five or more years combined experience with the following automation systems:
o Emerson Delta-V DCS system.
o Rockwell Automation SCADA and PLC Platform.
o ABB Robot and Mitsubishi roller bottle machine
o Emerson Delta-V DCS system.
o Electronic Batch Reporting Systems Design and implementation experience.
o Process Control Network design including network segregation.
o Process Control Systems: Virtual Infrastructure design and implementation.
o System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
o Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.]]> Mon, 09 Mar 2026 00:00:00 EDT 1 Top 3 technical  skills that are required for the role:

1. Strong Background in Quality Systems related to Supplier Controls
2. Proven Excellence in Problem Solving - DMAIC, CAPA, or similar
3. Experience in SAP, Agile, and Track Wise (Nice to Have)

Education Required: Bachelor's Degree and 4 years of relevant experience OR advanced degree with a minimum of 2 years relevant experience

Responsibilities may include the following and other duties may be assigned.

·         Ensures that suppliers deliver quality parts, materials, and services.

·         Leads cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.

·         Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.). 

·         Coaches team members on supplier quality principles, quality system requirements, statistical analysis, and application of technical analysis to daily assignments.

·         Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.

·         Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

·         Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

·         Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

·         Provides technical guidance and quality compliance for Supplier Quality engagement throughout the product’s lifecycle. Including implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.

·         Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.

·         Define Receiving Inspection requirements as required and associated test method validation for internal companyTest Methods.

·         Evaluates and acts as a lead in processing and approving supplier change requests.

·         Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

·         Supports internal and external audit and inspections, including preparation and resolution of audit and inspection findings

·         Collaborates cross-functional with internal stakeholders and interacts with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.
]]> Mon, 09 Mar 2026 00:00:00 EDT 1 The Data & Systems Engineer contributes to the design, implementation, and governance of scalable data, analytics, and compute platforms supporting scientific and enterprise functions. This includes working with Databricks (Unity Catalog), AWS cloud infrastructure, and Posit analytical environments to enable secure, reliable, and efficient workflows.

Key Accountabilities
Technical Architecture
• Support development of reference architectures for data, analytics, and compute platforms.
• Ideate, develop, and document system design architecture and define and refine technical standards as needed.
• Assist with modeling data flows, source-to-target mappings, and governance frameworks.
• Participate in design reviews for Databricks, AWS, and Posit platform capabilities.


Platform Engineering & Integration
• Support development and optimization of ETL/ELT pipelines in Databricks with Unity Catalog and Delta Lake.
• Assist with AWS architecture including S3, Glue, IAM, Lambda, EC2, EMR, and CloudWatch.
• Contribute to integrations between Databricks, Posit Workbench/Connect, and scientific data platforms.
• Support CI/CD and IaC workflows using Terraform, GitHub Actions, and AWS-native tooling.


Governance & Compliance
• Support data governance initiatives including Unity Catalog permissions and lineage tracking.
• Assist with platform security reviews, compliance controls, and audit readiness.
• Contribute to documentation of architectural standards and operational safeguards.


Stakeholder Engagement
• Collaborate with scientists, engineers, and platform teams to understand requirements.
• Support onboarding, training, and documentation for Databricks, AWS, and Posit users.
• Participate in platform roadmap discussions and capability assessments.


Essential Skills & Experience
• Hands-on experience with Databricks (Unity Catalog, Delta Lake, clusters, notebooks).
• Knowledge of Posit Workbench/Connect/Package Manager and R/Python workflows.
• Experience with AWS services: S3, IAM, Lambda, EC2, Glue, EMR, CloudWatch.
• Ability to develop automation and workflows using Python, SQL, R, Bash, or PowerShell.
• Understanding of cloud architectures, data engineering patterns, and system integrations.


Desirable Skills & Experience
• Hands-on modeling experience creating architecture diagrams (Visio, Draw.io, SqlDBM).
• Exposure to Terraform, CloudFormation, or GitHub Actions.
• Familiarity with scientific computing environments or R&D workflows on a global scale.

Education Requirements
Candidates should possess a Bachelors or Masters degree in Computer Science, Data Engineering, Information Systems, or a closely related discipline, or demonstrate equivalent professional experience in a relevant technical field.]]> Mon, 09 Mar 2026 00:00:00 EDT 1 Additional position details from the manager below:

1. Can you please confirm your top 3 skills sets required?  Validation, Technical Writing, Problem Solving
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Validation Gap Assessment, Change order creation and documentation update, Revalidation/remediation activities to close gap assessments
3. What products (if any) will this role support?  Fusion Hollow Fiber Oxygenator (HFO) and Cardiotomy Venous Reservoirs (CVR)
4. What is your target years of experience?  5-15

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Mon, 09 Mar 2026 00:00:00 EDT 1 As a Senior DevOps Engineer you will be the primary builder and operator of cloud-native Digital Pathology infrastructure. You will focus on automating the secure, scalable hosting of image management systems (VMS) and AI workloads primarily within AWS, while managing connectivity to enterprise applications in Microsoft Azure. You will own the “Infrastructure as Code” (IaC) strategy, ensuring that the massive storage requirements of Whole Slide Imaging (WSI) and the burst-compute needs of AI inference are handled with efficiency, security, and strict GxP compliance. This role acts as the bridge between on-premise scientific computing and the limitless scale of the cloud.

Responsibilities:
Design and implement secure, scalable cloud architecture on AWS (S3, EC2, Batch, Lambda) using Infrastructure as Code (IaC) tools such as Terraform or CloudFormation
Automate intelligent storage lifecycle and tiering policies (for example, S3 Intelligent-Tiering and Glacier) to manage petabyte-scale pathology image archives cost-effectively while ensuring rapid retrieval for clinical review
Build and maintain robust CI/CD pipelines (for example, Jenkins, GitHub Actions, or Azure DevOps) to automate testing and deployment of AI models, integration scripts, and application updates
Implement comprehensive observability and reliability practices using monitoring and alerting tools (CloudWatch, Datadog, Splunk) to track system health, API latency, and data pipeline performance, ensuring high availability for clinical services
Manage secure cross-cloud networking and API connectivity between the AWS data plane and Azure-based enterprise systems (such as LIMS, billing, and ESB), ensuring seamless identity management and data flow
Enforce security-by-design principles by managing IAM roles, encryption keys (KMS), and network security controls to maintain compliance with HIPAA, GDPR, and GxP standards
Manage containerized workloads using Docker and Kubernetes to support portable AI inference and microservices that scale dynamically based on lab volume
Education, Experience & Qualifications:
Bachelor’s Degree or equivalent work experience required
5 or more years of experience in DevOps or Cloud Engineering with a primary focus on AWS environments required
Previous experience managing Azure resources in Terraform preferred
Extensive experience with Infrastructure as Code (IaC), specifically Terraform (preferred) or AWS CloudFormation
Proven track record of managing hybrid cloud networking (Direct Connect/VPN) and cross-cloud integrations, including connecting AWS services to Azure AD or API Management
Experience in regulated industries (healthcare, finance, biotech) managing sensitive data (PHI/PII) is strongly preferred
Hands-on experience with container orchestration (EKS, ECS, or Kubernetes) and serverless computing
AWS mastery with deep knowledge of core services, including S3 (object locking and lifecycle), EC2 and Auto Scaling, VPC networking, IAM, and Lambda
Proficiency in Python, Bash, or Go for automation and glue code
Expertise in building CI/CD pipelines using Jenkins, GitLab CI, GitHub Actions, or Azure DevOps
Strong understanding of encryption standards (TLS, AES), secrets management (Vault or Secrets Manager), and least-privilege access control
Functional knowledge of Azure AD, Azure Functions, or Azure API Management to support integration tasks ]]> Mon, 09 Mar 2026 00:00:00 EDT 1

6?month contract

An international biopharmaceutical organisation is delivering a major capital project and is looking for an experienced Senior Claims Manager to strengthen its project services function. This is a site?based role within a high?visibility work package, partnering closely with procurement, contracts, engineering, and external delivery partners.
The Role
You’ll take ownership of the project’s commercial claims landscape, ensuring issues are surfaced early, managed proactively, and resolved in a structured and pragmatic way. This role suits someone who thrives in the field, builds trust quickly, and has the confidence to navigate complex stakeholder environments.
What You’ll Do

• Drive the internal process for commercial claim settlements
• Lead contract close?out activities
• Partner closely with the project’s EPCM organisation
• Align with internal stakeholders including legal, finance, procurement, contracts and technical SMEs
• Act as escalation point for ongoing supplier and contractor claims
• Identify and mitigate risks to contractual milestones through active communication
• Provide regular reporting on claim status and progress
• Attend project meetings and ensure stakeholders are kept informed on mitigations and recovery actions
• Conduct regular site walks to validate progress and uncover potential issues
• Bring a forensic, fact?based approach to evaluating claims and risks
• Lead with pragmatism, problem?solving, and hands?on engagement
• Provide team leadership and coaching where needed

What You Bring

• Strong technical background, ideally with prior field experience
• Bachelor’s degree
• 10+ years’ experience in project environments
• Proven experience as a Senior Claims Manager, including team management
• Excellent communication and negotiation skills, Fluent English
• Highly visible, self?driven, and proactive in engaging stakeholders

]]> Mon, 09 Mar 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required?

• • Hands-on experience in mobile software development
  • Experience creating and managing backlogs, tracking execution, and driving delivery
  • Strong communication skills and ability to collaborate effectively across teams

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• • Own end-to-end delivery of an assigned mobile software release
  • Translate product features and requirements into structured, execution-ready backlogs and user stories
  • Track delivery metrics and drive execution discipline across development and test teams.

What is your target years of experience?  Bachelor’s degree in Software Engineering, Computer Science or equivalent with 5 to 8 years of managing delivery of advanced applications for mobile platform. 

 
TECHNICAL SKILLS
Must Have

• 2 years of experience writing Software, Java, Python, C
• Agile Metrics
• Agile Product Owner
• agile sprint
• Android
• Mobile Software Development
• Project Planning
• Software Project Management
• Technical Leadership
• technical software project management

Nice To Have

• DevOps tools like GitHub
  GitLab
  Kotlin
  Kotlin Multiplatform (KMM)
  PTC Codebeamer

 
Careers That Change Lives 

The Pelvic Health R&D team is one of the most cutting edge groups within the company, defining and executing on technology and architectural strategy using skills that span a variety of domains including Mobile Apps (Android), cloud, data analytics, web services, 2d/3d visualization, machine learning, and interfacing with embedded software for management and control of interconnected medical devices.

As a Senior Software Engineer (Project Engineer – Mobile), you will lead execution for a defined mobile software release pipeline, working with motivated, diverse, and knowledgeable development teams. You will collaborate with Product Engineering, Development, and Test Leads to translate requirements into actionable plans, create structured backlogs, and drive high-quality delivery. This role requires a mix of technical expertise, project execution, and leadership to deliver reliable, impactful mobile software that improves the quality of life of people around the world.
 

A Day in the Life 

• Own end-to-end delivery of an assigned mobile software release
• Translate product features and requirements into structured, execution-ready backlogs and user stories
• Lead backlog refinement, sprint planning, and overall release planning
• Approve and accept completed work in the ALM system using technical and quality judgment
• Apply technical judgment to evaluate approaches, challenge assumptions, and ensure architectural alignment and quality
• Partner with Product Engineering, Development, and Test Leads to ensure scope clarity, accurate task breakdown, and alignment with product intent
• Support prioritization discussions and maintain alignment with product strategy and system dependencies
• Identify risks and dependencies and drive mitigation plans
• Track delivery metrics and drive execution discipline across development and test teams
• Collaborate with stakeholders and communicate status, risks, and dependencies to leadership
• Ensure compliance with quality systems and software lifecycle processes
• Support regulatory deliverables in collaboration with engineering and test leads
• Promote engineering best practices and continuous improvement

 

Must Have: Minimum Requirements

• Bachelor’s degree in Software Engineering, Computer Science or equivalent with 8 to 10 years of managing delivery of advanced applications for mobile platform.
• Hands-on experience in mobile software development
• Android development experience (Kotlin or Java); familiarity with Kotlin Multiplatform (KMM) is a plus
• Understanding of mobile testing strategies and quality practices
• Experience working in Agile/Sprint-based development environments
• Ability to work at both technical detail and release-level view
• Experience creating and managing backlogs, tracking execution, and driving delivery
• Strong communication skills and ability to collaborate effectively across teams
• Strong attention to detail and an ability to deal with ambiguity

 

Nice to Have

• Good understanding of Continuous Integration environments (Jenkins, Bamboo, ElectricCloud)
• Experience with iOS platforms.
• Experience with configuration management tools and best practices (GIT, SVN, etc.).
• Ability to think strategically and execute methodically.
• Excellent written and oral communication skills. 
• Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
• Ability to influence cross-functional teams without formal authority.

]]> Mon, 09 Mar 2026 00:00:00 EDT 1
This is a hands-on role for a multidisciplinary expert focused on solving the core mechanical challenges at the heart of our next-generation platforms. You will be responsible for concepting, designing, building, and testing novel electro-mechanical, pneumatic, thermal, and fluidic solutions that ensure the ultimate performance, reliability, and longevity of our systems.

The Principal Mechanical Engineer will play a vital role in driving innovation for our next-generation instrumentation. We are looking for someone that exhibits a high degree of motivation, independence, and resourcefulness to help us develop solutions to novel DNA Sequencing and automation challenges in a fast-paced and collaborative environment.

Core Responsibilities
You will lead the end-to-end mechanical design and development of mechanical sub-systems including electro-mechanical, pneumatic, fluidic, and thermal components.
You will collaborate with engineers from other disciplines (electrical, consumables, materials) to define and manage all critical technical interfaces for your module.
You will develop novel mechanisms for automated reagent and flow cell loading, clamping, and sealing, ensuring reliability over repeated use.
You will architect and design thermal control systems, including the specification and integration of heating/cooling elements, sensors, condensation control, and heat management.
You will partner with internal and external simulation experts to guide and validate CFD, thermal, and optical models, using empirical data to refine designs.
You will serve as the primary technical expert for your sub-system during integration, verification, and troubleshooting activities, working directly with the Systems Integration team.
You will lead cross-functional design reviews, driving alignment and resolving technical trade-offs between mechanical design, consumables, materials, and assay requirements.
You will drive the technical execution for sub-systems, manage timelines for your design deliverables, and contribute to the overall project plan.
You will create and maintain all design documentation for your sub-systems, including detailed CAD models, drawings, and specifications.
You will contribute to the technical strategy for the future integrated system, providing data-driven recommendations on architecture and technology choices based on your sub-system's performance.
You will present technical progress, data, and design trade-offs to the broader project team and key stakeholders, clearly articulating the rationale and impact of engineering decisions.

Who You Are: (Required)
You have a PhD in Mechanical Engineering, Bioengineering, or a related discipline with at least 3 years of relevant industry experience; or a Master's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 4 years of relevant industry experience; or a Bachelor's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 7 years+ of relevant industry experience.
You have demonstrated deep, hands-on expertise in the design, development, and testing of complex mechanical, electro-mechanical, and pneumatic systems, preferably for life science or diagnostic instrumentation.
You have demonstrated hands-on expertise in thermal management and the design of precision temperature control systems.
You have experience developing fluidics systems and their interfaces including pumps, valves, tubing, sensors, and material selection.
You possess strong proficiency in 3D CAD software (e.g., SolidWorks) for detailed design and the creation of manufacturing drawings.
You have expertise designing components for a variety of manufacturing processes (e.g., machining, injection molding, 3D printing).
You are a creative and resourceful problem-solver, with the ability to troubleshoot complex issues at the interface of hardware, software, and chemistry.
You are proficient with common machine shop tools, as well as test and measurement equipment; proficient with rapid prototyping technology such as 3D printers, laser cutters, CNC mills/lathes, etc; and
You have a demonstrated level of proficiency with Python, LabVIEW, or similar tools for device control and data acquisition.

Preferred:
You have demonstrated the ability to lead technical projects and mentor junior engineers, providing clear guidance and delegating tasks to achieve project goals.
You have experience using simulation tools (CFD, FEA) to guide design decisions.
You have previously worked on the development of next-generation sequencing (NGS) or other genomics instrumentation.
You have experience working in a regulated product development environment
You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts; you excel at problem-solving skills and the ability to work under ambiguous situations.
You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner.

Pay ranges between 65-80/hr based on experience ]]> Sat, 07 Mar 2026 00:00:00 EST 1 We are seeking a skilled Temporary Senior Electrical Technician to support testing, troubleshooting, assembly, and validation of electronic systems, boards, and subsystems.
This temporary role involves hands-on work with PCB soldering and assembly, cable assemblies, test fixtures, and mechanical/electrical documentation.
The technician will collaborate closely with electrical, mechanical, and software engineers to support system integration, ensure functionality, and maintain compliance with quality and regulatory standards.

Key Responsibilities:
• Perform hands-on testing, troubleshooting, and debugging of electronic boards, subsystems, and complete systems.
• Assemble, solder, and inspect PCBAs, including through-hole and surface mount components, ensuring proper component placement and solder quality.
• Assemble, inspect, and verify cable assemblies, including signal, power, and interconnect cables.
• Design, set up, and maintain test fixtures for boards and subsystem validation.
• Develop and maintain mechanical and electrical documentation packages for test Fixtures, including drawings, schematics, and test reports.
• Perform basic fabrication tasks to support prototyping and test fixture development.
• Support verification, validation, and regulatory compliance activities (e.g., ISO 13485, FDA 21 CFR Part 11).
• Collaborate with engineers, software, and mechanical teams to support system integration.
• Handle optical components carefully when required (optics handling experience is a plus).
• Mentor junior technicians on soldering, test procedures, troubleshooting, and proper handling of electronic components.
• Maintain and organize test equipment, tools, and lab resources.
• Identify issues and provide recommendations for corrective actions during testing and troubleshooting.

Requirements
Required Qualifications:
· Associate or bachelor’s degree in Electronics, Electrical Engineering Technology, or related field.
· 5+ years of hands-on experience testing, troubleshooting, and validating electronic systems and boards.
· Strong PCB soldering and assembly skills (through-hole and surface mount).
· Experience assembling and testing cable assemblies and interconnects.
· Experience using test equipment (power supplies, signal generators and o-scopes)
· Experience designing, setting up, and using test fixtures for PCBAs and subsystems.
· Proficiency with MS Office; familiarity with SolidWorks, OrCAD, Arena PLM, or Altium is a plus.
· Strong documentation skills for test reports, cable layouts, and subsystem validation.
· Basic fabrication skills (cutting, drilling, assembly) for prototyping and fixture support.
· Good understanding of analog, digital, and mixed-signal electronics.
· Excellent written and verbal communication skills.
· Self-starter with the ability to work independently with minimal direction.
· Well-organized, detail-oriented, and able to prioritize tasks effectively.

Pay $30-33/hr ]]> Fri, 06 Mar 2026 00:00:00 EST 1
ECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor, working under limited supervision, and providing assistance and training to lower level employees. Runs minor projects, including performing tests, interpreting data, developing reports.

Organizational Impact: Performs technical activities requiring considerable judgment and may have ownership of minor projects. Work consists of technical tasks that are typically not routine.

Innovation and Complexity: Technical problems faced are general, and may require some analysis to understand and resolve. Expected to independently propose solutions to problems for supervisor review.

Communication and Influence: Communicates typically with internal contacts . Obtains and provides technical information on matters of moderate importance to the job area.

Leadership and Talent Management: Responsible for providing guidance, coaching and training to other employees within job area.

Required Knowledge and Experience: Requires complete and broad knowledge of operational systems, techniques and practices typically gained through extensive experience and/or education.

Requires minimum of 4 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.]]> Fri, 06 Mar 2026 00:00:00 EST 1 ABOUT THE POSITION

The Senior Cold Chain Engineer will own the design, implementation, optimization, and continuous improvement of LN2 and temperature-controlled supply chain systems supporting research, clinical, and future commercial operations. This role is highly autonomous and requires deep technical expertise, strong project execution skills, and the ability to translate scientific and regulatory requirements into scalable operational solutions. They will be expected to be the primary supply chain contact for various internal and external teams, representing the team in many high-profile projects.


KEY RESPONSIBILITIES

Cold Chain System Design & Engineering

• Design, qualify, and optimize LN2, cryogenic, frozen, refrigerated, and CRT cold chain systems across internal and external networks.
• Lead the selection, qualification, and lifecycle management of: LN2 storage tanks and freezers, Cryogenic and passive shippers, and Temperature-monitoring devices and telemetry solutions
• Define temperature excursion tolerances, hold times, and stability-aligned packaging strategies.

Operational Readiness & Scale-Up

• Build cold chain capabilities to support R&D, clinical trials, and future commercial scale.
• Develop and execute cold chain strategies aligned with Long-term storage requirements and global distribution and site variability
• Serve as the cold chain SME during process development, tech transfer, and scale-up initiatives.

Qualification, Validation & Risk Management

• Lead cold chain IQ/OQ/PQ, lane qualification, packaging validation, and re-qualification activities.
• Author and review validation protocols, reports, and technical assessments.
• Conduct failure mode and risk analyses for cold chain processes and shipping lanes.
• Design and implement mitigation strategies for LN2 and CO2 supply interruptions, equipment failures, and transit risks.

Quality, Compliance & Documentation

• Ensure cold chain operations comply with GxP, and internal quality standards.
• Partner with Quality to develop and maintain:
• SOPs, work instructions, and deviation response playbooks
• Temperature excursion investigation frameworks
• Support audits, inspections, and regulatory readiness activities related to cold chain operations.

Vendor & External Partner Management

• Act as the technical lead for cold chain vendors, couriers, and logistics providers.
• Evaluate vendor capabilities, lead technical due diligence, and support contracting decisions.
• Drive continuous improvement through performance reviews, root-cause investigations, and CAPAs in alignment with Quality.

Data, Monitoring & Continuous Improvement

• Define KPIs and dashboards for cold chain performance (excursions, lane reliability, cost, recovery time).
• Leverage temperature data, shipment analytics, and trend analysis to proactively improve system robustness.
• Champion standardization and best-practice adoption across programs and geographies

Cross-Functional Leadership

• Serve as the cold chain subject-matter expert across Supply Chain, Manufacturing, Quality, Clinical Ops, Commercial Ops, and R&D.
• Translate scientific, regulatory, and operational needs into executable cold chain solutions.
• Independently identify gaps, propose solutions, and drive projects from concept through implementation.
• Performs other duties as assigned

Requirements
QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree in engineering, supply chain, life sciences, or related technical field (required). Master's degree in engineering, supply chain, life sciences, or related technical field (preferred).
• 7–12+ years of experience in cold chain engineering, logistics, or operations within biotech, pharma, cell/gene therapy, or biologics.
• Relevant certifications a plus: Cold Chain or GDP certifications Six Sigma / Lean methodologies

REQUIRED SKILLS AND ABILITIES

• Hands-on experience with LN2 and cryogenic cold chains (storage, shipping, and monitoring) with biologics.
• Proven track record of owning complex technical projects end-to-end with minimal oversight and ability to operate independently. 
• Direct experience with packaging qualification, lane validation, and temperature excursion management.
• Proficiency in Microsoft Office Suite, DocuSign, and Smartsheet.

 ]]> Fri, 06 Mar 2026 00:00:00 EST 0

We are seeking a Senior Electrical Engineer to lead the design and development of advanced electro?mechanical products within a highly regulated environment. This role spans the full product lifecycle — from early technology development through to verification, commercialization and ongoing enhancements. You will work closely with cross?functional teams globally, while mentoring junior engineers and driving technical excellence across multiple projects.
What You’ll Do

• Design electronic assemblies and PCBAs for complex electro?mechanical products.
• Ensure all electrical designs meet regulatory and compliance requirements (UL, IEC, FDA).
• Conduct EMI, safety and manufacturability testing to ensure robust, compliant designs.
• Collaborate with mechanical, software, systems and quality engineering to align schedules, budgets and project milestones.
• Apply failure?analysis and root?cause investigation skills to resolve product or component issues.
• Generate detailed design specifications, test protocols and technical reports.
• Contribute to and lead technical design reviews to ensure electrical integrity and product safety.
• Mentor junior engineers and support team capability development.

What You Bring

• 4+ years’ experience in electronics engineering with strong analog, digital and mixed?signal circuit design, plus PCB development.
• Experience designing regulated products, ideally within the medical device sector, including exposure to UL, IEC, FDA and EMI/EMC testing.
• Full product?lifecycle experience developing and verifying electro?mechanical systems from early concept through commercialization.
• Hands?on experience with failure analysis, root?cause techniques and writing design specifications, test protocols and technical documentation.
• Degree in Electronics Engineering or equivalent relevant experience.
• Excellent communication skills and ability to work effectively within cross?functional teams.

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Full-time l 12 month contract

A major capital project in the life sciences sector is seeking an experienced LOTO / PTW Specialist to join its EHS team. This role is central to ensuring safe isolations, strong permit governance, and high quality field execution across a complex, high risk environment.
The Role
You will manage project specific LOTO processes and isolation equipment, combining structured coordination with hands on site presence. You’ll support safe work planning, guide stakeholders, and help maintain a strong safety culture throughout the project.

Key responsibilities include:

• Managing the project LOTO office and overseeing isolation processes.
• Supporting safety line walks, coordination meetings and permit discussions.
• Reviewing PTW, job hazard assessments and RAMS for safe task execution.
• Leading and supporting risk assessments with engineers and contractors.
• Verifying LOTO plans through PI&D review and advising on process safety requirements.
• Supervising field EHS performance, including occasional nights and weekends.
• Developing safety communication material and delivering LOTO and process safety training.
• Coaching employees and contractors and escalating issues when needed.
• Supporting the wider EHS team and acting as PTW back up when required.

What You Bring

• 5+ years’ experience with LOTO and PTW in high risk industries (life sciences, energy, petrochemical or similar).
• Experience working on large, complex projects.
• Engineering background or similar technical qualification.
• Strong understanding of barrier management, high integrity, and the ability to work independently and within a small team.

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Summary:

Looking for an engineer specialized in industrial utility systems and plumbing. 

 

Primary responsibilities for role:

• Will design the following system types:
• Steam, Chilled Water, Heating Hot Water, Compressed Air, Natural Gas, and Plumbing

Develop construction documents for industrial and commercial code compliant underground plumbing systems.

Specify technical utility equipment: boilers, chillers, cooling towers, heating hot water skids, air compressors, receivers, tanks, and other parts of the listed system types thru development of user requirements, P&IDs, equipment sizing calculations, equipment specifications and datasheets.

Modify existing or develop new piping, material, and equipment specifications to meet requirements of project scopes.

Perform vendor & bid evaluations, progress monitoring, and attendance of factory acceptance testing.

Field supervision of contractors during construction to ensure safety, quality, and schedule.

Work as part of a multidiscipline team to design, start up and commission new systems.

Provide contractors answers to questions that arise during construction, review/approve component submittals, issue field notices as needed.

Ensure drawings are as-built, document commissioning, prepare turnover package.

Ensure compliance with company, environmental, building code, and regulatory policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.

Analize existing utility systems and infrastructure and reconfigure to support new operations.

Function as site subject matter expert for industrial utility design and construction.

Provide the necessary calculations for all equipment sizing associated with the utility systems.

These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is not required but shall be considered a plus for the candidate.
 

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

 

Additional Responsibilities:

Meets customer expectations and continuously improves process technology or capital process through improved productivity and quality, in consultation with internal departments and external resources. Maintains awareness of governmental, industry, and academic developments. Usually participates with a technical or industry association external to the company. Works efficiently with people to transfer technology into the business. Transfers knowledge for the good of the corporation. Leads installation, qualification, and integration into process controls of mechanical systems. Develops objectives and implementation plans for a team of engineers. Works with a core team and management to continue to develop and define the approach for the organization. Participates in identification, justification, development, and implementation of strategies and communicates the ideas to the core team. 

 

Knowledge, Skills, and Abilities:

Possesses adequate communication skills necessary in interacting with internal and external customers. Report-writing skills are important to help prepare clear and concise updates to clients and co-workers. Must be computer literate and have knowledge of such software programs as Microsoft Office that is helpful in creating reports, spreadsheets, and system design plans. Must also be well-organized and have the ability to facilitate meetings ensure reports are organized and prepared in advance to present to intended parties. Excellent oral and written communication skills with the ability to present complex ideas in clear and simple terms. Strong problem solving skills. Ability to analyze and identify areas for improvement.

 

Education and Experience:

Bachelor’s degree in engineering or related field from an accredited university and be able to obtain a NC PE license. Other professional registration and/or certifications as appropriate.

Minimum of 6 years of industrial experience. Experience in Biotech or Chemical industry preferred.

Experience designing following system types: Steam, Chilled Water, Heating Hot Water, Compressed Air, Natural Gas, and Plumbing is highly desired

HVAC experience is not required but shall be considered a plus for the candidate.

Direct experience with AutoCAD, PipeFlo, Revit, Plant 3D is not required but will be considered a plus for the candidate.
               

Equivalency:

Depending on the area of assignment, related experience or a combination of related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate’s degree with 6 years of experience, or a master’s degree with 2 years of experience.

 

Occupational demands:

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32°F in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Repetitive foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs.

 
]]> Fri, 06 Mar 2026 00:00:00 EST 1

Full time l 12 months contract

A major capital project in the life sciences sector is seeking an experienced Process Safety Specialist to support safe commissioning and execution across a complex and highly regulated environment. You will play a central role in risk analysis, process safety leadership and incident management while working closely with system owners and commissioning teams.
The Role
You will take a leading role in process safety activities and drive clarity, structure and safe work practices throughout the project.

Key responsibilities include

• Leading risk analysis for high risk activities and working with system owners to establish clear method statements
• Facilitating structured risk workshops including HAZID sessions and HAZOP sessions
• Acting as safety lead on system walks and pre startup safety reviews during commissioning
• Conducting incident investigations and supporting continuous improvement
• Contributing to a strong safety culture through clear communication and structured facilitation

What You Bring

• Five plus years of experience in technical or process safety within highly regulated and high risk industries such as life sciences energy or oil and gas
• Strong understanding of barrier management and preferably bow tie methodology
• Background covering operations design construction and commissioning on large scale projects
• Experience as a lead incident investigator
• A naturally structured communicator and facilitator with strong stakeholder skills

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignments. General responsibilities include design concept generation, participating in design reviews, development and testing to assess performance against design specification; reliability testing, and assessment of system interactions. Makes independent decisions. Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions.

Job Responsibilities/Qualifications
• Candidates should be able to perform each of these responsibilities satisfactorily to do this job successfully
• Learns to use company concepts, policies and procedures, familiar with and follows standard practices.
• Normally receives detailed directions on all work.
• Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Makes suggestions to improve work processes.
• Assists in reducing to practice patentable inventions.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Participates in technical team activities.
• Presents and discusses data within group.
• Monitors work to ensure quality, and continuously promote Quality First Time.
• Other duties as assigned by management.

Required Skills:
- Knows basic and some specialized engineering techniques.
• Familiar with searching technical literature.
• Skilled with use of word processing, spreadsheets, graphical and presentation software
applications.

Experience/Education:
- Bachelors in Engineering with 4+ years of experience

Pay ranges between 40-45/hr based on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1

We’re looking for an experienced Multiskilled Maintenance Engineer to join a fast?paced manufacturing environment, supporting high?speed processing and packaging equipment. You’ll play a key role in keeping production running smoothly through proactive maintenance, rapid fault?finding, and continuous improvement.

The role:
You’ll carry out planned and reactive maintenance on a range of electro?mechanical machinery, troubleshoot breakdowns to minimise downtime, and work closely with production teams to ensure lines operate at peak efficiency. Keeping documentation and CMMS records up to date, supporting improvement projects, and maintaining a strong safety focus are all essential parts of the position.

What we’re looking for:
A Time?Served Apprentice or qualified engineer (ONC/HNC/NVQ Level 3) with solid mechanical and electrical skills. Experience with processing/packaging machinery, PLC fault?finding, drives, and circuits from 415V downwards is highly beneficial. You’ll be comfortable working in a fast?paced manufacturing setting, adaptable to change, and confident analysing and resolving technical issues. Familiarity with systems such as SAP, Maximo, and Microsoft Office is an advantage.
]]> Thu, 05 Mar 2026 00:00:00 EST 1 Play a critical role in the development of new life science technology as a reliability engineer in the R&D group.  Provide hands-on, analytical, and reliability expertise to support engineering programs associated with the development of complex instruments.  Work in a team environment to assess and improve product reliability throughout the design process.  Manage reliability projects by implementing tests, analyzing data, assessing reliability risks, and reporting accurate information to stakeholders.

 

Primary duties include the following:

• Lead and monitor multiple reliability projects.
• Provide reliability risk assessments to cross-functional teams and executive leadership.
• Create and implement test plans to effectively mitigate risks in new product designs.
• Facilitate and direct multidisciplinary discussions to evaluate technical risk through FMEA.
• Leverage internal and external resources to complete reliability test plans.
• Record, organize, and manage large amounts of detailed test data.
• Methodically analyze test data and interpret results for critical reliability decision-making.
• Troubleshoot instrument failures and/or reliability issues as necessary.
• Direct, execute, and document root cause investigations.
• Guide the team to corrective action identification, implementation, and validation.
• Escalate top issues by providing clear, well-structured, high-level updates.
• Provide engineering input for new designs to ensure reliable and robust products.

 

Minimum Qualifications:

Education and Experience:

• Minimum of a Bachelor's degree in engineering or related discipline required.
• Minimum of 5 years of reliability engineering experience or experience performing tests to collect experimental data and performing statistical analyses to interpret results. (2 years may be substituted with advanced degree in engineering or related discipline)
• Knowledge of reliability fundamentals and understanding of reliability analysis (i.e., life predictions, product life modeling, root cause analysis, environmental testing, accelerated testing, etc.)
• Applies technical standards, principles, concepts, and techniques to solve problems.
• Excellent communication skills.
• Willingness to work in BSL2 lab
• Willingness to prepare blood samples for testing (training will be provided).

 

In addition to the above minimum qualifications, the following are considered highly desirable:

• Knowledge of fluidic, optical, and/or electro-mechanical systems.
• Experience with test automation (LabView, Arduino, etc.).
• Experience utilizing FMEA to guide team discussions and priorities.
• Statistical knowledge, especially related to six sigma tools and methodology, design of experiments, and reliability modelling.
• Experience managing large sets of data using data processing tools such as Minitab, MATLAB, JMP, or R.

Fully onsite
Pay $40-50/hr based on experience]]> Thu, 05 Mar 2026 00:00:00 EST 1 Candidate Details
2+ to 5 years experience
Minimum Education - Associate's Degree
Willingness to Travel - Occasionally
Ideal Candidate
Using hand tools and test equipment, the individual will perform maintenance on both electronic and mechanical equipment, such as industrial controls, computers, and servo-mechanisms, following blueprints and manufacturer’s specifications. Performs duties within cGMPs for Medical Devices, maintaining change control, notifying QA/RA and engineering where necessary and makes adjustments only within documented and validated limits. Ensures compliance with quality systems, policies, procedures and best practices, and all local, state, federal and safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English.
Duties/Responsibilities:     

• Perform troubleshooting, diagnosis causes and repair equipment.
• Perform preventative maintenance (PM's) on equipment.
• Maintain parts inventory.
• Support engineering projects-ordering and installation of new equipment, new equipment IQ's.
• Continuous Improvement projects to reduce expenses, improve reliability, and reduce waste.
• Test electronic circuits to locate defects and understand the use of oscilloscopes, signal generators, amp meters, and voltmeters. 
• Install, modify and understand control panel wiring. Work closely with the Controls group to understand and modify PLC programs and maintain PLC ladder logic programs.
• Train operators and assist with machine set-ups/operation as required.
• Work with central crib to maintain an inventory of spare parts, both fabricated and commercial.   Perform troubleshooting and repair of pneumatic and mechanical systems.
• Propose design changes and review with engineer to upgrade equipment, eliminate re-occurring problems, improve product quality, reduce costs, etc. 
• Duties may require correction of problems during off shifts on a call-up basis. Work closely with tool room to make timely repairs.   Work schedules may fluctuate due to product and process start up or machine issues, as well as training of new associates on the off shifts.  Must be flexible and willing to work overtime when needed.    
• Other duties as required to support the needs of the business

Education:

• High School Diploma or GED required
• Associates Degree in a technical field preferred
• In Lieu of Associates Degree, two years technical experience required

Knowledge, Skills and Abilities:

• Thorough understanding of hydraulic, electric, mechanical and pneumatic systems - Proficient
• Ability to read blueprints and schematics - Proficient
• computer skills (SAP, Excel, Word preferred) - Basic
• Ability to maintain accurate records - Proficient

Relocation assistance available ]]> Thu, 05 Mar 2026 00:00:00 EST 1 The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
1. Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
2. Proven problem-solving skills.
3. Makes measurable improvements to processes and procedures.
4. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
5. Acts as a team member representing Quality on new product development and sustaining engineering projects.
6. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.
7. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).
8. May perform other duties as required.

Education and Experience:
Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:
• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
• Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures
• Able to make presentations
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
o Acceptance sampling theory and application
o Statistical process control methods and application
o Measurement system/test method knowledge and analysis
o Quality planning
o Failure analysis investigation
o Design of Experiments
o Process mapping and value stream analysis
o Hypothesis testing
o Descriptive statistics
o Process capability analysis
o Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
o Risk Management
o Supplier quality management
o Auditing
o Design/development tools
o Process validation
o Software validation
]]> Thu, 05 Mar 2026 00:00:00 EST 1
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Wed, 04 Mar 2026 00:00:00 EST 1 Location:   Luimneach, Munster, Ireland

Req Number: 3435286

Salary: 60-70k EUR


Job Description Summary:

As a Design Assurance Quality Engineer (QE), you will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards. Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes while driving adherence to global regulatory requirements. Your responsibilities will span from product inception through launch and maintenance, requiring strong collaboration with cross-functional teams and effective communication skills.

You will lead risk management activities, manage Design History File (DHF) documentation, and support compliance initiatives such as IEC 60601 and IEC 62304. The role involves reviewing and approving verification and validation plans, challenging statistical rationales, and authorizing deviations. You will also assist in failure investigations, software issue tracking, and advocate for a strong quality culture across projects. Additionally, you will contribute to broader Quality Management System (QMS) activities, including CAPA, field assessments, and operational engineering evaluations.

About the role:

As Quality Engineer - Design Assurance, you will be involved in new product development and product sustaining projects through the application of Quality Engineering skills. You will balance multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.

You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements. The Design Assurance QE represents the Quality Function on the Project core teams for both new product development and existing products.

Main responsibilities: 

• 
  Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with core team members and extended quality functions as needed for the project.
  
• 
  Contribute to the formation and ongoing management of DHF documentation
  
• 
  Lead risk management activities within the project.
  
• 
  Drive compliance management activities (e.g., IEC 60601) on the project with support from the Compliance Engineer.
  
• 
  Demonstrate a patient-first approach to quality engineering.
  
• 
  Support the creation and implementation of verification and validation activities.
  
• 
  Work closely with R&D functions to ensure comprehensive testing of product requirements and the execution of the V&V plan.
  
• 
  Review and approve testing procedures and documentation.
  
• 
  Review and challenge the statistical rationale and data analysis within the test protocol and reports.
  
• 
  Assess and authorise related execution deviations.
  
• 
  Assist/conduct Failure investigations and problem-solving sessions.
  
• 
  Responsible for the software issue tracking process per IEC 62304 to ensure software issues are logged, risk assessed and dispositioned appropriately.
  
• 
  Ensure compliance across projects for design control, risk management, and change control processes.
  
• 
  Advocate for a strong quality culture within project core teams
  
• 
  Support of other QMS activities outside of projects, such as CAPA, Field Assessment and operations engineering assessments.
  

 

About you

• 
  A relevant degree or equivalent experience (engineering degree preferred), or a minimum of 5 years of quality engineering experience as an equivalent qualification
  
• 
  Knowledge in working with ISO 13485, QSR, ISO 14971, and statistical techniques
  
• 
  Expertise in design assurance, including design controls, standards compliance, and risk management
  
• 
  Strong written and verbal communication skills
  
• 
  Strong organisational skills
  
• 
  Experience with MDR – advantage
  
• 
  Experience with IEC 62304 and IEC 62366 – advantage
  
• Ability to influence. Assess the situation and determine if a blocking issue is triggered.

*7+ to 10 years experience
Mid-Senior
Minimum Education: Bachelor's Degree
Willingness to Travel: Occasionally]]> Wed, 04 Mar 2026 00:00:00 EST 1 The Facilities Engineer will assist in the day-to-day operation and maintenance of the facilities across multiple sites within the RTP Hub.

Responsibilities

· Work with Facilities & Engineering team to manage and maintain proper building functionality inside and outside of laboratories including but not limited to, emergency and non-emergency power systems, HVAC units, cold storage, RODI water systems, air compressors, vacuum pumps, and other major utilities systems

· Perform daily site walk through and verify functional check on all major systems and utilities that are critical to our daily operations

· Assist with monitoring the building management system (BMS) as needed, investigate the issue(s), and follow procedures for the appropriate solution according to the issue(s)

· Troubleshoot and diagnose equipment or utilities problems, document findings and report back to the Facilities & Engineering team to work through a solution. Execute facilitating the solution if the task has been assigned to you to carry out

· Attend weekly Facilities & Engineering stand-up team meetings and update team on status of individual action items

· Participate in key project planning meetings with capital projects along with the facilities team, raising concerns and pursuing resolutions during project planning meetings, implementation, and delivery of assigned projects

· Support project delivery and monitor progress through assigned project deliverables, providing updates and recommendations to the internal engineering team

· Manage and maintain timely completion of service ticket requests from all internal users

· Coordinate with the internal customer on status updates of complex issues that develop into projects from work orders

· Collaborate across departments such as EH&S, QA, Lab Operations and Capital Projects to achieve group success in a number of stakeholder and vendor facing challenges

· Work to comply with safety initiatives set forth by EH&S to ensure departmental and organizational compliance

· Assist lab operations and department requests for equipment setup within various labs across the organization

 

About you:

· BS/BA required.

· 4-7 years’ experience in Engineering/Facilities role required.

· Background in mechanical or electrical engineering a plus.

· Strong building utilities systems & HVAC experience preferred with working knowledge and experience using BMS systems.

· Prior pharma & experience working in a laboratory

· Possess basic office skills using a PC and working with MS office tools (Word, Excel, and PowerPoint).

· Skills and experience utilizing CMMS systems, CAD, and other Design programs a plus

· Self-motivated, organized, individual capable of working independently as well as a team contributor.

· Strong oral and written communication skills.

· Excellent interpersonal skills with the ability to interact effectively with teams, internally and externally.
]]> Wed, 04 Mar 2026 00:00:00 EST 1
Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.; Skills:? previous intern experience is a plus? experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.]]> Wed, 04 Mar 2026 00:00:00 EST 1

We are seeking a Lead Mechanical Design Engineer to drive the design, development and verification of complex medical devices across both capital equipment and disposable components. This is a hands?on technical leadership role where you will guide cross?functional teams, oversee full lifecycle engineering, and deliver innovative, manufacturable and compliant solutions within a regulated environment.
What You’ll Do

• Lead the end?to?end design, development and verification of complex assemblies, sub?assemblies, components and packaging.
• Select materials, manufacturing processes, tooling and automation solutions to meet performance, cost and scalability needs.
• Translate product requirements into detailed engineering specifications and conduct feasibility studies and proof?of?concept testing.
• Drive design and process optimisation to improve quality, performance and manufacturability.
• Lead risk?management activities including PHA, FTA and dFMEA/uFMEA.
• Perform root?cause analysis and implement corrective actions following failure investigations.
• Collaborate with manufacturing teams to troubleshoot issues and refine process parameters.
• Manage projects or sub?projects, guide cross?functional teams and apply structured project?management methodologies.
• Support supplier and subcontractor activities and lead technical reviews with internal and external stakeholders.
• Provide team leadership including recruitment, performance oversight and daily activity coordination.
• Stay current with emerging engineering tools, technologies and methods to elevate team capability.

What You Bring

• 5+ years’ experience in medical?device mechanical design, ideally spanning capital equipment and disposable components.
• Full product?lifecycle experience: design, development, verification and optimisation.
• Strong background in material selection, manufacturing processes, GD&T, DFM/DFA, DOE and root?cause analysis.
• Proven experience running risk?management activities (PHA, FTA, dFMEA/uFMEA).
• Demonstrated project and team leadership, with clear ownership of deliverables and cross?functional coordination.
• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering or equivalent.
• Deep understanding of design for manufacturability/assembly and modern engineering practices.
• Strong communication skills and ability to influence decisions through technical insight.
• Familiarity with medical?device regulatory frameworks (ISO 13485, MDR, FDA 21 CFR 820).

]]> Wed, 04 Mar 2026 00:00:00 EST 1 Additional position details from the manager below:

1. Can you please confirm your top 3 skills sets required?
   1. Bachelor’s degree in engineering, science, or related discipline
   2. Strong written and verbal com-munication skills with ability to work as part of a cross functional team
   3. Experience with post market complaints, trending, issue escalation
   4. Nice to have: experience with reliability testing and/or design verification
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Post market complaint investigation including regulatory request responses
   2. Managing issue escalations for post market products
   3. Updating/maintaining risk files
3. What is your target years of experience?
   1. 1-3 years

Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience]]> Tue, 03 Mar 2026 00:00:00 EST 1 *depending on experience

Description:
The Senior project Engineer 3 oversees the seamless transition of manufacturing processes from one location to another, ensuring minimal disruption. Responsibilities include coordinating with cross-functional teams, managing timelines, and maintaining product quality during the transfer. The role requires expertise in process optimization, problem-solving, and compliance with industry standards. Strong communication skills are essential for liaising with stakeholders, including engineering, quality, regulatory, supply planning, procurement, and production teams. Senior Project Engineer 3 also monitors and reports on progress, ensuring that all project objectives are met efficiently.

What will you be doing.
• Manage the transfer of manufacturing processes between locations, ensuring minimal disruption to production.
• Create detailed project plans, including timelines, resource allocation, and milestones for the transfer process.
• Work closely with engineering, quality assurance, regulatory, supply planning, procurement, production teams, and suppliers to align objectives and address potential issues.
• Identify opportunities for process improvement and implement changes to enhance efficiency and product quality.
• Ensure all processes adhere to industry standards, safety regulations, and company policies.
• Track and report on the progress of the transfer project, addressing any deviations from the plan.
• Resolve any technical or logistical problems that arise during the transfer to avoid delays and maintain production continuity.
• Prepare documentation and provide training to ensure the receiving location can operate the new processes effectively.


What will you need to be successful?
• Bachelor’s degree in science or engineering and at least 5 years’ professional work experience in new product development, product transfer in a regulated industry (Med Device preferred).
• Experience with medical device manufacturing methods is highly desirable.
• Communicate optimally, while working with multi-functional teams, to achieve desired results.
• Build productive internal/external relationships and collaborate in teams.
• Complete assignments with directional input and periodic mentorship.
• The ability to understand, interpret, follow, and improve Inspection, gauging methods and different Quality Systems.
• Requires organizational and time management skills.
• Understand basic technical issues and develop solutions with scope of responsibilities.
• Basic knowledge of Operations deliverables / documentation is preferred.
• Duties and responsibilities may change as business needs change.
• Having GD&T knowledge will be beneficial.
• Strong verbal and written communication and presentation skills.]]> Tue, 03 Mar 2026 00:00:00 EST 1 Join Our Team as an Aftermarket Service Engineer – Elevate Your Engineering Career!
 

Are you a proactive, detail-oriented engineer with a passion for high-precision testing and servicing within the cleanroom and containment industries? We’re seeking two talented Aftermarket Service Engineers to deliver exceptional on-site service, support critical testing processes, and help our clients maintain the highest standards of operational excellence. This is your chance to work in a dynamic, fast-paced environment with travel opportunities across the UK—and occasionally overseas—while making a tangible impact in cutting-edge industries.

What You’ll Do:

• Conduct on-site testing, calibration, and servicing of containment and cleanroom equipment, including airflow testing, DOP testing, particle counting, and filter integrity assessments.
• Maintain and calibrate test equipment, ensuring compliance with industry standards.
• Troubleshoot electrical and mechanical faults, supporting operational integrity.
• Compile detailed reports and documentation for each service visit.
• Promote additional service, upgrade, and spares opportunities.
• Travel extensively throughout the UK (and internationally as required), working independently and as part of a team to deliver scheduled and ad-hoc maintenance projects.
• Collaborate closely with clients, site personnel, and internal teams to ensure operational success and safety compliance.

What We Need From You:

Required Skills:

• Proven experience with airflow testing, DOP testing, particle testing, and filter integrity assessments.
• Strong electrical and mechanical troubleshooting skills.
• Excellent organizational skills and meticulous attention to detail.
• Ability to work independently with minimal supervision.
• Good communication skills for client interactions and reporting.
• Valid driving license and willingness to travel extensively.

Nice to Have Skills:

• Experience working within cleanrooms, GMP environments, or containment industries.
• Background in servicing or commissioning medical, pharmaceutical, or high-containment equipment.
• Knowledge of calibration procedures and test equipment maintenance.
• Basic knowledge of PLCs, HMIs, and automation systems.

Preferred Education & Experience:

• Engineering apprenticeship, HND/HNC qualification, or relevant technical training in instrumentation, testing, or engineering disciplines.
• Prior experience in airflow testing, particle counting, containment, or similar sectors.

Additional Requirements:

• Willingness to travel 90-100% of the time, including overnight stays.
• Experience or familiarity with GMP standards is advantageous.
• Must uphold strict health and safety standards, report issues proactively, and be adaptable to varying project demands.

Take the next step in your career today—apply now to join a forward-thinking company where your skills will be valued, and your growth supported!
]]> Tue, 03 Mar 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required? 

• Circuit Debugging experience
  PCBA Design and test experience
  Proven Hands on Electronic Mechanical Skills 

Can you please confirm the 3 main responsibilities/day to day activities required for this role? 

• Board test plan and initial execution
  Track, determine root cause, recommend solutions to issues identified by hardware and cross functional teams 
  Manage prototype hardware in the lab/local locations 

What is your target years of experience? 5-10 Years 

When do you plan to start interviewing?? ASAP 

Will you be looking to hire and start ASAP or will the start date be delayed?  April 6th is the earliest Start date 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?? Onsite 4 days a week? 
_____________________________________________________________________________________________________

Job Responsibilities may include  

• 
  Manage prototype hardware in the lab/local locations 
  
• 
  State of PCBAs 
  
• 
  Apply/ensure rework is consistent across all systems (include directing technicians to perform this work) 
  
• 
  Manage software/PL installed on the systems/PCBAs 
  
• 
  Support software, systems possibly DA with PCBA 
  
• 
  Issue debug 
  
• 
  Board test plan and initial executifon 
  
• 
  Receive initial Boards 1 PCBAs 
  
• 
  Develop low level checkout 
  
• 
  Ohmic checks 
  
• 
  Initial power on 
  
• 
  Low level register testing (per PCBA if applicable) 
  
• 
  Lead technicians once initial PCBAs are tested 
  
• 
  Resource as test failures occur 
  
• 
  Debug failures with technician assist. 
  
• 
  Assist with EMC test setup (local internal prescreen and local test house) 
  
• 
  Work hand in hand with PL team to test hardware interface and expected results 
  
• 
  Develop/test board functions, ADC interfaces, DAC interfaces as needed. 
  
• 
  Bridge External Contract House, Systems team, DA team and EE team on catheter simulator design 
  
• 
  Assist with PCBA testing for first units 
  
• 
  Design lab test fixtures, test boards to support functional testing for EE team, systems team 
  
• 
  Participate in design reviews for schematics, layout 
  

 
Position Overview: 

The Sr. EE is an individual contributor within our technical functions, responsible for advancing existing technology and introducing new technologies and therapies. This role involves formulating, delivering, and managing assigned projects, collaborating with various stakeholders to achieve desired outcomes. The Sr. EE may mentor colleagues or oversee the work of lower-level professionals. Most of their time is dedicated to delivering R&D, systems, or initiatives related to new technologies or therapies—from conception through implementation—while adhering to company policies and leveraging specialized knowledge and skills. 

Key Responsibilities: 

• 
  Research, develop, design, and test electrical components, equipment, systems, and networks. 
  

• 
  Design electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes. 
  

• 
  Formulate, deliver, and manage projects, working with cross-functional teams to achieve project goals. 
  

• 
  Mentor colleagues and provide guidance to entry-level professionals and employees in the Support Career Stream. 
  

• 
  Participate in design reviews for schematics and layout. 
  

• 
  Assist with testing and development of PCBA units and lab test fixtures. 
  

• 
  Bridge communication between external contract houses, systems teams, DA teams, and EE teams on design projects. 
  

Differentiating Factors: 

• 
  Autonomy: Operates independently with general supervision, handling larger and moderately complex projects or assignments. 
  

• 
  Organizational Impact: Sets objectives for their job area to align with project and assignment goals, contributing to project milestones and occasionally participating in cross-functional assignments. 
  

• 
  Innovation and Complexity: Addresses general problems and issues that may require a broad understanding across job areas. Makes adjustments or recommends enhancements to systems and processes to solve problems or improve job area effectiveness. 
  

• 
  Communication and Influence: Communicates primarily with internal contacts to share information, status, needs, and issues, supporting decision-making processes. External interactions are typically straightforward and focused on problem-solving. 
  

• 
  Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and employees in the Support Career Stream. 
  

• 
  Required Knowledge and Experience: Requires practical knowledge and demonstrated competence in the job area, typically obtained through advanced education combined with relevant experience. 
  

]]> Tue, 03 Mar 2026 00:00:00 EST 1   JOB DESCRIPTION
This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day to day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.

This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have  quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests. 

 
Responsibilities:

• Provide ongoing quality engineering support throughout the product life cycle.
• 
  Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
  
• 
  Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions.
  
• 
  Support process risk management activities and ensure quality and completeness of validation packages, and change orders.
  
• 
  Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
  
• 
  Review verification and validation reports and identify gaps for GMP compliance.
  
• 
  Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
  
• 
  Coordinate issue resolution using a risk-based approach.
  
• 
  Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
  
• 
  Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
  
• Collaborate with counterparts and cross-functional teams at other sites.
• 
  Other activities as assigned.
  

]]> Tue, 03 Mar 2026 00:00:00 EST 1 Test Technician – Robotic Platforms

 

As a Test Technician, you’ll be in driving projects through the product verification process for Hugo RAS, using your results driven work ethic, collaborative spirit, and solution facilitation skills. You will be supporting various systems engineering test activities such as integration, verification, reliability testing, analysis, hardware and software troubleshooting, and more. 

 

Careers that Change Lives

 

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

 

A Day in the Life

·         Execute test methods and simulated procedures on the robotic-assisted surgery system. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation.

·         Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.

·         Document system performance and usage, and communicate hardware or software issues.

·         Perform simulated bedside assist functions including positioning the system components and introduction and removal of test materials.

·         Perform manual setup and tear down activities, including cleaning of all equipment surfaces, and orienting medical equipment for daily storage and transport within the lab space.

·         Conducts laboratory support functions such as inventory and maintenance on supplies and equipment.

·         Perform periodic workflows test methods including manually transporting equipment throughout the facility, taking measurements to evaluate system functional performance over time, and emergency simulation or response activities.

·         Execute batches of repetitive cycling of ergonomic adjustments and interactions with user interfaces including buttons, switches, touch screens, and medical equipment control surfaces.

·         Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental.

·         Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems . May be required to highlight areas of concerns/problems in own job area.

Must Have: Minimum Requirements

Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.

Nice to Have

• 3+ years of technician experience in the medical device or regulated industry
• Ability to create accurate diagrams and document equipment configurations.
• Ability to quickly learn new or unfamiliar technology and products.
• Fundamental understanding of computers and basic experience with networking and upgrades.
• Basic knowledge in circuit boards and electronics.
• Understanding of hardware and software interactions, communications, and troubleshooting.
• Ability to diagnose system failures, isolate, reset, or replace faulty components.
• Experience with purchasing, tracking, and receiving equipment.
• Experience assembling office equipment, electronic equipment, electronic assemblies.
• Experience leading and seeking guidance to complete laboratory maintenance needs.
• Experience setting, running, and execution of test procedures.

]]> Mon, 02 Mar 2026 00:00:00 EST 1 Pay 55-70/h depending on experience

Top 3 technical  skills that are required for the role:

1. Demonstrated experience in validations IQ, OQ, PQ

2. Demonstrated experience with running medium to large capital projects

3. Experience with statistical methods

Education Required: Baccalaureate degree preferably in engineering (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)

Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. 

Will the contractor be working 40 hours a week? If not, weekly estimate?

40 hours a week possible overtime needed.

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?

Onsite

What is your timeline for scheduling interviews?

Would like to start interviews by early March.

What product line will this person support?

They will support the Electron Beam that cures the gel used as a part of our PolyHesive Pad production.

 

Responsibilities may include the following and other duties may be assigned.

• Provide engineering support for our electron beam manufacturing line ensuring optimal operation, performance, and adherence to policy.
• Manage changing priorities and respond quickly to challenges in a fast-paced, dynamic manufacturing environment.
• Design, develop, and improve manufacturing processes, procedures, and production layouts for product assembly, equipment installation, and material handling.
• Work closely with R&D, Quality, and other cross-functional teams to drive the integration of new technologies, process changes, and continuous improvements.
• Validate new components, systems, and process changes to ensure product performance, quality, and efficiency.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Adapts machine or equipment design to factory and production conditions.
• Ensure all manufacturing processes, equipment, and procedures comply with industry regulations and standards, with a focus on maintaining safety and product integrity.
• Mentor and coach junior engineers and team members, providing guidance in design, troubleshooting, and process optimization.

 

Required Knowledge and Experience: 

·         Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

·         Practical knowledge of project management.

·         Strong attention to detail.

·         Strong written and verbal communication skills.

·         Strong technical aptitude with ability to troubleshoot complex interconnected systems, interpret schematics, and offer effective solutions.

·         Demonstrated experience in validation.

·         Ability to manage changing priorities and maintain productivity in a high-paced, evolving environment.

·         Experience with statistical methods preferred.

·         Experience in manufacturing and/or regulated industry strongly preferred.

·         Experience with running medium to large capital projects preferred.
]]> Mon, 02 Mar 2026 00:00:00 EST 1 *depending on exp

Ideal candidate is an Automation Technician (2 years) with strong hands-on PLC troubleshooting skills, ladder logic reading, HMI familiarity, and packaging equipment experience. Able to collaborate with mechanical techs, and adept at diagnosing electrical/automation issues in a GMP manufacturing environment. Industry background is flexible; key requirement is practical automation experience. Strong communication and problem-solving skills are essential.

In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.

Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Support cGMP validation of equipment and processes.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
Support Operations using Current Good Manufacturing Practices (cGMP).
Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.]]> Fri, 27 Feb 2026 00:00:00 EST 1
The Sr. Associate Facilities for a Final Drug Product Operation Facility will be part of the Facilities & Engineering team responsible for providing maintenance leadership and technical expertise in support of safe and reliable facility infrastructure, facility equipment/systems, electrical systems, instrument standards, utility systems, and/or production suites and ensures:
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
• Supports the efficient operation of site facility infrastructure systems (to include all utility systems, electrical systems, etc.).
• Monitors all system status and analyzes to identify trends.
• Develops maintenance strategies and programs (preventative, corrective, predictive etc.) to ensure cost effective and reliable operation of all plant equipment and systems.
• Facilitates business units' capability to perform their functions.
• Working in a regulated cGxP environment, identifies engineering needs for site facilities.
• Defines projects, develops innovative solutions, determines engineered solutions, develops project documentation, obtains capital or expense resources.
• Represent site as Facilities SME.
• Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures (SOPs).
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to facility equipment/systems.
• Solving complex problems, project management, equipment lifecycle management and operational excellence.
• Drawing management for Facilities and Supporting areas.
• Determining facility and equipment specifications.

Basic Qualifications:
Bachelors degree in Engineering (Mechanical, Electrical or Chemical) + 2 years Engineering and/or Facilities Maintenance work experience.
High school/GED + 8 years Engineering and/or Facilities Maintenance work experience OR
Associates + 4 years Engineering and/or Facilities Maintenance work experience.]]> Thu, 26 Feb 2026 00:00:00 EST 1
IDEAL QUALIFICATIONS:
• Drug Substance Bioprocessing background required.
• 2+ years Prior experience in process development/ /Process Engineering environment, clinical or commercial scale manufacturing, or tech transfer, with specific experience in the implementation, scale up, and support of biopharmaceutical manufacturing processes.
• Experience leading or supporting process optimization/ continuous improvement projects
• Some understanding of regulatory and cGMP requirements.
• Experience with project management. Has the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management.
• Some experience with digital tools and/or data visualization software (e.g. Tableau, Spotfire, Smartsheet, Sharepoint, AI tools).
• Excellent written and verbal communication.
• Able to adapt to changing business needs and operational requirements.
• Experience with issue resolution and ability to influence across support organizations.
• Bachelors degree (Chemical Engineering, Bioengineering or Biotechnology, computer science, or other quantitative discipline)

IDEAL BEHAVIORS:
• Enjoys tackling challenges, working in teams, and excels at organizing information from numerous sources to provide well-constructed deliverables.
• High attention to detail and quality in work.
• Ability to collaborate well cross-functionally between departments and work closely with team members to accomplish larger tasks.
• Passion for proactively identifying opportunities and solutions through creative data analysis.
• Intellectual curiosity with ability to learn new concepts/frameworks and technology rapidly as needs arise.
• Ability to problem solve, conceptualize solutions independently, escalate issues appropriately, and integrate feedback.
• Ability to ask clarifying questions and seek guidance when necessary.
• Ability to manage multiple projects simultaneously and deliver results in a timely fashion.
• Accountable, Self starter, and quick learner

WORK MAY INCLUDE, BUT IS NOT LIMITED TO THE FOLLOWING:
• Optimization of business processes related to Drug Substance pharmaceutical manufacturing, such as technology transfer.
• Generate business process documentation such as Guidelines, job aids, templates, and Standard Operating Procedures (SOPs), with feedback from SMEs and management.
• Collaborate with partner organizations to develop and deploy digital business process solutions to facilitate knowledge management and business process execution.
• Support strategy development to identify tech transfer business process pain points and deploy solutions to improve processes.
• Collaborating with multiple stakeholders to understand project timelines, create a project plan, and execute the project deliverables in a timely fashion.
• Develop visualization dashboards to communicate OKRs, metrics, and process improvements. Deliver presentations to management and cross-functional partners.

*CO/NYC candidates might not be considered]]> Thu, 26 Feb 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required?

    Data driven problem solving

    Solid understand and application of regulatory requirements

    NCRs, Complaint Investigation, Site Transfers, Site Shutdowns

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

   Day to day sustaining operations quality support

   NCR Ownership

   Complaints DHR and manufacturing assessment

What is your target years of experience?  More than 5 years of mfg/operations experience

 

 
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Thu, 26 Feb 2026 00:00:00 EST 1
Engineer - Complaints Technical Investigator:

Requires a combination of working remote and going onsite 2 to 3 times per week (average) for complaint returns assessment and/or laboratory equipment setup, development and validation of test methods.

Job Description
-Currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of the mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.

JOB RESPONSIBILITIES:

Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends

Provide input to engineering for product improvements

Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms

Lead root cause analysis to identify the failure mode for products and associated components due to product complaint

Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, 5 Whys, risk assessments such as FMEAs, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.

Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation

Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data

Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

PREFERRED QUALIFICATIONS

Masters Degree in Science
5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
Understand customer / patient use of packaged and/or distributed products
Understand manufacturing processes for packaged and/or distributed products
Proven experience with medical devices
Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
Experience with protocol and report writing, process and test development and execution, and design of experiments
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong technical writing and interpersonal skills

Committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.]]> Wed, 25 Feb 2026 00:00:00 EST 1 *Depending on experience

Summary:
The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints, and evaluate product integrity and standards.

Job Responsibilities:
• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
• Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
• Strong leadership and collaboration with other leaders in project and across the organization
• Mentor engineers in understanding of quality systems and strategies within new product development.
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
• Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
• Train, coach, and guide lower-level employees on more complex procedures
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic leadership and mentoring skills necessary to provide support and constructive performance feedback.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.]]> Wed, 25 Feb 2026 00:00:00 EST 1
Role Description:

The Supplier Quality Engineer II will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Operations, Quality, Sourcing, and RA.

Job Function:

• Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Works with suppliers to ensure quality system and supplied product requirements are understood and successfully met.
• Responsible for helping define supplier qualification requirements for OEM and custom materials and devices.
• Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and Industry best practices.
• Supports completion of Design Development File requirements applicable to supplied components, subassemblies, devices, and services.
• Supports risk management and validation activities with suppliers.
• Develops inspection methods and procedures for receiving inspection and/or supplier final release.
• Executes test method validation activities for receiving inspection and/or supplier final release.
• Knowledge of NCR & CAPA elements is preferred.
• Assesses non-conformances and leads closure of SCARs as needed.

Required Education / Qualifications:

• Bachelors degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions
• Highly regulated industry experience

Preferred Qualifications:

• Engineering degree
• Experience with supplier quality engineering activities, including external supplier vendor audits
• Effective problem-solving techniques and experience with technical tools (i.e. Root Cause Analysis, dFMEA process, Gage R&R, etc.)
• Proficient understanding of Design Controls, test method development & validation, and risk management.
• Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
• Experience with class II and class III medical devices
• Medical device, pharma, biotech or other regulated industry experience
• Demonstrated ability to apply statistical quality engineering tools
• Ability to read and interpret drawings
• Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred.
• Ability to manage multiple and frequently changing projects and priorities.
• Ability to work independently without close supervision
• Effective communication and conflict resolution skills
• Highly developed time management, communication, and documentation skills
• Strong communication and organizational skills to effectively manage and get results with external suppliers
• Six Sigma Black Belt/LEAN Manufacturing experience
• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
• Domestic and international travel up to 25% (post-COVID)]]> Wed, 25 Feb 2026 00:00:00 EST 1 Head of R&D Brachy Solutions

Seeking an inspiring and strategic leader to helm our R&D Brachy Solutions division, driving innovation and excellence in a highly regulated industry. This pivotal role offers the opportunity to lead a dynamic, multidisciplinary team of 60-70 experts in developing cutting-edge software and hardware products that directly impact patient care. As the cornerstone of our innovation pipeline, you will shape the technology roadmap, ensure disciplined project execution, and foster a culture of continuous improvement—all while collaborating with cross-functional partners and maintaining full regulatory compliance. This is your chance to make a meaningful difference in medical technology while advancing your leadership career in a forward-thinking organization.

Required Skills:

• Proven senior leadership experience managing large R&D teams (20+ staff), with a background in software development, AI, and regulated industries such as medical devices.
• Strong track record in product lifecycle management, including delivery of new product development (NPD), upgrades, and sustaining activities within scope, timeline, and budget.
• Extensive experience in project portfolio management, resource planning, and cross-functional collaboration.
• Exceptional communication skills in English, with the ability to effectively engage with internal teams, external research partners, and supply chain stakeholders.
• Demonstrated ability to set and execute strategic roadmaps, including product management and innovation drivers.
• Sound understanding of regulatory standards such as MDR/CE and FDA/510(k), and familiarity with design controls, verification & validation processes.
• Strong leadership qualities, including the ability to say no, manage multiple priorities, and motivate a high-performance culture.

Nice to Have Skills:

• Experience in software development involving AI applications, especially in medical or healthcare technology.
• Background in securing R&D subsidies, scientific research collaborations, and managing IP/IP strategy.
• Knowledge of hardware components related to medical devices and their integration with software solutions.
• Fluency in Dutch or experience working in the Netherlands would be advantageous but is not mandatory.

Preferred Education and Experience:

• Master’s degree in Engineering or a related scientific field; PhD preferred.
• At least 10+ years of progressive leadership experience in R&D, preferably within regulated industries such as medical technology.
• Demonstrated success leading multidisciplinary teams in fast-paced, innovative environments.

Other Requirements:

• Must be willing to work on-site in Utrecht, Netherlands, five days a week; occasional remote work is acceptable but not regular.
• Open to relocation support for qualified candidates.
• Ability to build strong relationships with clinical, regulatory, and commercial teams.
• A proactive, results-driven mindset aligned with ethical values, focusing on impactful patient outcomes and efficient resource utilization.

If you are ready to lead groundbreaking R&D initiatives in a company dedicated to transforming patient care through innovation, we encourage you to apply and become a key driver of our next chapter.

]]> Tue, 24 Feb 2026 00:00:00 EST 1 *depending on exp

Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. Additional responsibilities will include support in development of audit readiness materials and gmp documentation generation and review. This is an on site position.

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Day to day responsibilities: 
General validation and commissioning support, generation and management of documents, support of audit readiness, other engineering support tasks.
 ]]> Tue, 24 Feb 2026 00:00:00 EST 1 Mechanical Engineer - II

Join a dynamic team as a Mechanical Engineer - II and play a vital role in supporting cutting-edge manufacturing operations. Based at our facility in Ireland, this full-time, fixed-term position offers the opportunity to contribute to innovative engineering solutions in a collaborative environment. If you are passionate about industrial systems, have a strong technical background, and thrive in a hands-on setting, this is your chance to make a meaningful impact.

What You’ll Do:

• Provide expert engineering support for manufacturing processes, technology, and systems.
• Maintain and repair plant infrastructure and equipment, ensuring optimal performance.
• Collaborate with cross-functional teams to troubleshoot issues and implement improvements.
• Work with moderate supervision, demonstrating independence and technical expertise.
• Apply your experience to support ongoing operations and technology upgrades.

Required Skills:

• Solid understanding of mechanical systems, maintenance, and repair.
• Proven ability to work independently and self-direct tasks.
• Strong problem-solving skills and attention to detail.
• Excellent communication and collaboration abilities.
• Demonstrated understanding of manufacturing or industrial environments.

Nice to Have Skills:

• Experience with systems engineering or automation technologies.
• Knowledge of health and safety standards related to manufacturing.
• Prior exposure to plant infrastructure maintenance.

Preferred Education and Experience:

• Relevant degree or diploma in Mechanical Engineering or a related field.
• Significant experience in manufacturing or industrial engineering roles.
• Experience working in a fast-paced, onsite environment.

Other Requirements:

• Fully onsite role
• Occasional flexibility for WFH, dependent on operational needs.
• Must hold necessary certifications or qualifications pertinent to mechanical engineering support.

Take your career to the next level by contributing your expertise to our innovative team. Apply now to become a key player in our manufacturing success story!
]]> Mon, 23 Feb 2026 00:00:00 EST 1
Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings, and read and interpret blueprints.

Job Responsibilities:
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience required.]]> Wed, 18 Feb 2026 00:00:00 EST 1

0-2 years of experiences with testing and data analysis, creating test protocols and reports.

• 0-3 years of medical / clinical experience or exposure

Advanced Testing Knowledge

Packaging Testing
Nice To Have

• Basic laboratory mechanical testing skill
• Calibration

Responsibilities may include the following and other duties may be assigned. Sets up test apparatus and conducts tests of production assemblies and units following methods, procedures, standards, and sequences. Lays out and assembles units for production equipment according to designs and specifications. Adjusts and calibrates systems as needed. Modifies equipment by adding, removing, or altering components as defined by predetermined diagrams and sketches. Corrects malfunctions by making adjustments or replacing parts or components as directed. Uses hand and small power tools, and various measuring and testing devices in performing job duties. May monitor and verify quality in accordance with statistical process or other control procedures.

TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor, working under moderate supervision . Performs tests, interprets data and develops reports.

Organizational Impact: Performs intermediate technical activities requiring judgment and decisionmaking . Work consists of technical tasks that are typically routine.

Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems . May be required to highlight areas of concerns/problems in own job area.

Communication and Influence: Communicates typically with internal contacts . Obtains and provides technical information requiring some explanation or interpretation .

Leadership and Talent Management: May provide guidance and assistance to new or entry level employees.

Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.]]> Wed, 18 Feb 2026 00:00:00 EST 1 Validation Engineer II – (Hybrid Role)

Step into a pivotal role that drives excellence in quality assurance within the biotech or pharmaceutical manufacturing sector. As a Validation Engineer II based in Carlow, you will be at the forefront of ensuring the integrity and compliance of critical equipment and sterilization processes. This is a fantastic opportunity to apply your technical expertise in a dynamic, collaborative environment, supporting key validation projects that contribute to life-changing innovations.

What You’ll Bring to the Table:

• A strong background in engineering or science, with proven experience in equipment validation and sterilization validation.
• Excellent technical writing abilities, paired with clear and effective oral communication skills.
• Demonstrated experience in developing validation master plans, SOPs, protocols, and final reports.
• Skilled in executing validation studies and analyzing data to resolve technical challenges efficiently.
• Ability to work both independently and within cross-functional teams, managing validation projects with moderate supervision.

Nice to Have Skills:

• Experience with pharmaceutical or biotech manufacturing environments.
• Knowledge of regulatory standards and compliance requirements related to validation activities.
• Familiarity with sterilization methods, cleanroom procedures, or GMP guidelines.

Preferred Education and Experience:

• Bachelor’s degree in Engineering, Science, or a related field.
• Prior experience in equipment and sterilization validation, ideally within a regulated industry.

Other Requirements:

• Ability to work in a hybrid setting
• Strong attention to detail and organizational skills to manage multiple validation activities effectively.

If you’re ready to contribute your expertise to a role that makes a real impact, we encourage you to seize this opportunity and apply now. Make your next career move in validation excellence!
]]> Tue, 17 Feb 2026 00:00:00 EST 1 *depending on experience

Construction Manager -- NC
The Construction Manager will lead large-scale capital investment and site master plan initiatives within an active manufacturing environment. This role provides technical leadership across project management, construction execution, and operational readiness. You’ll be responsible for ensuring safe, high-quality delivery of complex projects while supporting long-term asset reliability and site performance objectives. The construction portfolio is approximately $100M in value.

Responsibilities
• Direct and oversee construction delivery teams, including internal project stakeholders, third-party construction management partners, and construction safety resources.
• Manage assigned construction scope to ensure safe execution, quality workmanship, and functional outcomes through hands-on, daily oversight of field activities.
• Collaborate with on-site engineering, design teams, system owners, and project engineering services to achieve construction milestones.
• Monitor daily field progress, proactively address site issues, and remove execution barriers.
• Review, assess, and resolve construction change notices as they arise.
• Drive schedule adherence by actively engaging field teams and leveraging site-based tools and collaboration systems.
• Maintain a strong construction safety culture aligned with internal safety standards and expectations.
• Lead coordination of construction activities that interface with existing operations, including implementation of clean construction practices.
• Review monthly cost reports and payment applications submitted by construction management partners.
• Partner with project controls to evaluate change requests, review invoices, and support monthly reporting.

Accountability & Reporting
• Provide weekly updates on construction progress, risks, and key milestones.
• Deliver monthly reporting on project financials, schedule status, and risk profile.
• Develop and maintain an integrated project schedule covering design, construction, commissioning/qualification, validation, and system turnover.
• Coordinate with external vendors, consultants, municipal authorities, and local utility providers as required.
• Ensure proper turnover of construction documentation, test records, materials, and certifications.
• Support development of SOPs, preventive maintenance schedules, and quality documentation for installed electrical assets.

Required Education and/or Qualifications
• Bachelor’s degree in Engineering or comparable technical experience.
• Minimum of 10 years of engineering experience, including at least 5 years managing capital construction projects.
• Strong knowledge of pharmaceutical construction practices and regulated manufacturing environments.
• Hands-on experience with pharma and biologics packaging facilities, equipment and packaging line installations.

Other Requirements
• Background in pharmaceutical manufacturing engineering across operations, maintenance, or capital project execution.
• Working knowledge of hygienic design principles, cleanroom electrical standards, and validation requirements.
• Solid understanding of the end-to-end project execution lifecycle.
• Experience using project management and scheduling tools, including web-based collaboration platforms.
• Willing to travel on average 20-50%, with extended on-site presence during active construction phases]]> Tue, 17 Feb 2026 00:00:00 EST 1 *Depending on experience

Our Senior Supplier Development Engineer position is a unique career opportunity that could be your next step towards an exciting future.
The Senior Supplier Development Engineer role will reside in the Advanced Technology (AT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews, supply chain readiness review and manage design transfers to manufacturing.

How you'll make an impact:
Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and receiving inspection fixture design for Test method validation.
Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
Develop and manage project milestones in line with development and commercialization needs.
Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
Audit suppliers for their technical capabilities as well as quality criteria.
Perform other duties and responsibilities as assigned.

What you'll need (Required Qualifications):
Bachelor's Degree or equivalent in Engineering or Scientific field with, 4 years experience including either industry or industry/education OR
Master's Degree or equivalent in Engineering or Scientific field with, 3 years experience including either industry or industry/education.
On-site work required.
Up to 20% domestic/international travel required.
What else we look for (Preferred Qualifications):
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
CAD experience using ProE/Solidworks
Strong analytical, problem solving and technical writing skills.
Strong Project management skills.
Ability to work well both independently and as a member of a team.
Effective verbal/written communication and interpersonal skills including conflict and relationship management.]]> Tue, 17 Feb 2026 00:00:00 EST 1 Validation Engineer - III

Are you a seasoned validation professional ready to make a meaningful impact in a dynamic environment? We are seeking a highly skilled Validation Engineer - III to join a forward-thinking team. This pivotal role offers the opportunity to lead critical validation projects, ensuring compliance and excellence in equipment performance, sterilization, and process validation within a state-of-the-art facility. If you thrive in a collaborative setting and have a passion for technical precision, this could be your next career move.

What You’ll Bring:

• Strong background in engineering or scientific disciplines
• Extensive experience with Equipment Validation and Sterilization Validation
• Proven ability to develop and author validation master plans, protocols, SOPs, and final reports
• Excellent technical writing and oral communication skills
• Ability to analyze validation data and resolve technical issues efficiently
• Capable of working independently and within cross-functional teams to meet project objectives

Nice to Have:

• Previous experience supporting validation during sterile or cleanroom environments
• Knowledge of GMP standards and regulatory requirements
• Additional certifications in validation or quality assurance

Preferred Education & Experience:

• Degree in Engineering, Life Sciences, or a related field
• Demonstrated experience in validation activities, especially sterilization processes, within a regulated industry

Other Requirements:

• Valid work authorization within Ireland
• Willingness to support validation studies involving cleaning and sterilization processes

Take this opportunity to be a critical part of advancing innovative solutions in a thriving industry. If you possess the expertise and drive to excel in validation engineering, we invite you to apply now and contribute to shaping the future of quality assurance in healthcare manufacturing.
]]> Mon, 16 Feb 2026 00:00:00 EST 1 Primary Responsibilities for Role:

• Electrical and Instrumentation (E&I) Engineer for the pharmaceutical industry.
• Will be required to manage assigned scope, cost, and schedule for responsible duties.
• Will work in all phases of capital projects: planning, design, procurement, construction and start-up:
• Design of low voltage power distribution and motor control.
• Responsible for selection and sizing of instrumentation based on P&IDs.
• Selects control system hardware based on site standards.
• Prepares equipment specifications and bid packages.
• Performs vendor & bid evaluations, progress monitoring and attendance of factory acceptance testing.
• Responsible to field supervise contractors during construction to ensure safety, quality and schedule.
• Responsible for providing contractors answers to questions that arise during construction.
• Performs equipment start-up, develops and executes commissioning protocols and prepares turnover packages for the site.
• Develops single lines, motor control schematics and loop sheets.
• Sizes electrical components based on NFPA 70.
• Modifies existing or develops new specifications to meet requirements of project scopes.
• Coordinates with other disciplines throughout design, construction and startup.
• Provides initial configuration settings for VFDs and Motor Starters.

Communication - Will be responsible for providing communications (verbal/written) within area of responsibility.

Use/demonstrate problem solving skills in order to best support and meet the needs within area of responsibility.

Promotes a collaborative and cooperative environment which embraces the ability to work effectively within teams.

Capable of adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control, Quality Oversight, Validation.
 

Education and Experience requirements based on level:

Staff Engineer Level:

Minimum Education: Bachelor's Degree in Engineering or related field.

Professional registration and/or certifications as appropriate.

Minimum of 5 years of related experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred.
 

Principal Engineer Level:

Minimum Education: Bachelor’s Degree in Engineering or related field.

Professional registration and/or certifications as appropriate.

Minimum of 8 years of experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred.
 

 Additional Requirements:

PE license in NC preferred.

Will require occasional international travel (i.e. Spain, Canada)
 

 

Occupational Demands:

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.
]]> Mon, 16 Feb 2026 00:00:00 EST 1 Summary
We are seeking a Electrical & Instrumentation Engineer to play a critical role in delivering reliable, compliant, and innovative solutions for complex capital projects. This position offers the opportunity to work across all phases of projects from planning and design to procurement, construction, and start-up while collaborating with multidisciplinary teams to make a global impact.
Primary Responsibilities
In this role, you will:

• Lead Project Scope: Manage assigned scope, cost, and schedule for all responsibilities.
• Design and Develop: Create low-voltage power distribution systems and motor control designs.
• Instrumentation Expertise: Select and size instrumentation based on P&IDs and site standards.
• Control Systems: Choose control system hardware aligned with site requirements.
• Technical Documentation: Prepare equipment specifications, bid packages, and detailed schematics including single lines, motor control diagrams, and loop sheets.
• Vendor and Contractor Oversight: Perform vendor evaluations, monitor progress, attend factory acceptance testing, and supervise contractors during construction to ensure safety, quality, and schedule adherence.
• Commissioning and Turnover: Execute equipment start-up, develop commissioning protocols, and prepare turnover packages.
• Compliance and Standards: Size electrical components per NFPA 70 and adhere to Good Manufacturing Practices (GxP), including compliance, change control, quality oversight, and validation.
• Collaboration: Coordinate with other disciplines throughout design, construction, and start-up phases.
• Configuration: Provide initial settings for VFDs and motor starters.
• Communication and Problem-Solving: Deliver clear verbal and written communication, demonstrate strong problem-solving skills, and foster a collaborative team environment.

Education and Experience Requirements Based on Level
Staff Engineer Level:
Minimum Education: Bachelor's Degree in Engineering or related field.
Professional registration and/or certifications as appropriate.
Minimum of 5 years of related experience. Experience in Biotech, Pharmaceutical, or Chemical Industry preferred.

 

Principal Engineer Level:
Minimum Education: Bachelor’s Degree in Engineering or related field.
Professional registration and/or certifications as appropriate.
Minimum of 8 years of experience. Experience in Biotech, Pharmaceutical, or Chemical Industry preferred.
Additional Requirements
PE license in NC preferred.
Occasional international travel required (e.g., Spain, Canada).

 

Occupational Demands:

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.

 
]]> Mon, 16 Feb 2026 00:00:00 EST 1
Summary:
This manufacturing engineering role will be responsible for planning and executing the move of commercial and NPD metals manufacturing lines into a new facility to align with future growth needs of the metals operation.

Job Responsibilities:
• Drive the line movement workstream of the metals facility move project as the technical project lead
• Develop and execute a process validation plan including IQ/OQ/PQ for manufacturing equipment as well as facilities utilities equipment
• Create robust shutdown & startup procedures to ensure minimal disruption to metals production & continued supply of critical components
• Liason with external suppliers for movement, calibration, and other activities as needed associated with the new facility
• Collaborate with internal cross-functional partners such as quality, project management, facilities, operations, supply chain, and other groups to ensure requirements are met & production delivery is maintained
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.

Skills:
• Equipment & Process Validation Experience
• Team player and detail oriented.
• Project management/project leadership experience
• Experience with highly complex/automated manufacturing equipment

Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.]]> Fri, 13 Feb 2026 00:00:00 EST 1 Per HM, candidates need to have knowledge of RJG Co-pilot system and setting up DC2 and DC3 processes or they will get rejected as this is required for the role

Top 3 technical  skills that are required for the role:

1. Injection Molding Process development
2.  Scientific Molding Principles
3.  Knowledge of RJG Cavity Pressure systems 

Education Required: BS In Plastics Engineering or equivalent

Years’ Experience Required: Minimum of 7 Years Experience Required

 


Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects and processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
]]> Tue, 10 Feb 2026 00:00:00 EST 1 Pay 50-60/h depending on experience

Top 3 technical  skills that are required for the role:

1. Leads successful validations of packaging systems for medical devices
2. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
3. Lead project meetings and provide updates to management

Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline

Years’ Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, onsite 4 days per week (North Haven CT or Lafayette CO) Please list which location at the top of the resume when submitting candidates

What is your timeline for scheduling interviews? ASAP

What product line will this person support? Various within Surgical OU


The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following:

 

• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
• Leads successful validation of packaging systems for medical devices
• Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
• Lead project meetings and provide updates to management.
• Assist in labeling development process.
• May perform and evaluate testing in a laboratory environment as per industry standards.

 

 

Minimum Requirements

 

• Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
• Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
• Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
• Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.
• Established and productive individual contributor with strong team and interpersonal skills.
• Knowledge of Microsoft Office programs is required.
• CAD/CAPE/TOPS Software knowledge is preferred.

]]> Wed, 04 Feb 2026 00:00:00 EST 1 Additional position details from the manager:
 

1. What products (if any) will this role support? Implantable Pacemaker and Implantable Cardioverter defibrillator testing
2. What is your target years of experience? Recommend 3 years of experience

_______________________________________________________________________________________________

This Test Engineer position is responsible for providing key technical expertise and organizational leadership and focus for developing the test capability necessary to evaluate products to meet standards compliance, regulatory approval, and business’s needs.  This position provide support that spans the full range of research, technology, and development of new and derivative products.

The Test Engineer will work with designers and reliability engineers and technicians to develop and execute strategies that provide the test capabilities necessary to drive decisions and support regulatory submission

Cardiac Rhythm Management (CRM) delivers innovative therapies and solutions for cardiac diseases, pain, and spasticity.
CRM delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

Responsibilities/ A Day in the Life

• Plan and provide test capabilities early in project development, and drive the identification and proper collection of test objectives, requirements, measures, and metrics. 
• Understand applicable product/system test requirements and provide inputs.
• Develop, validate, implement test methods and systems to meet design and reliability requirement by collaborating with Design, Reliability, Operations, Regulatory Affairs, and other cross-functional partners. Must be established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments

• Lead and execute Installation Qualifications (IQ)
• Perform re-validation on legacy methods and system
• Contribute to the completion of group objectives, through building relationships and consensus to reach agreements on assignments.
• Problem solver. Problem and issues faced in this position are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
• Make improvements to processes, systems to enhance better performance.
• Provide guidance, coaching and training to other lower engineers and Technicians
• Manage projects, delegation of work and review of reports from others.
• Lead and participate both mechanical and electrical test development.
• Communicate clearly the project plans and deliverables to management and project teams where applicable.
• Support ISO-17025 lab accreditation.

Must Have: Minimum Requirements (Must be evident on your resume)

• Bachelor’s in Mechanical or Electrical engineering, science or related technical field with 2+ years in Engineering

Nice to Have:  Preferred Requirements

• 2+ years of test engineering experience.
• Knowledge of Verification and Validation (V&V) practices and techniques.
• Problem solving skills, including demonstrated application of structured problem solving methods and tools

• Familiar with statistical analysis tools such as Minitab or JMP

• Experience with testing in both a manual and automated environment
• Familiar with ISO-17025 lab accreditation
• Proficient with MS Word
• Proficient with MS Excel

]]> Tue, 03 Feb 2026 00:00:00 EST 1

Can you please confirm your top 3 skills sets required?  Reliability Engineering, Test Method Development, Test Method Validation

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Setup and execution of test methods for Test Method Validation or Design Verification, Report writing and approval, Custom sample and/or fixture development.

What products (if any) will this role support?  CAS products (e.g., Affera, Pulse Select, AFA Pro, etc.)

What is your target years of experience?  1-3 years

When do you plan to start interviewing?  ASAP

Will you be looking to hire and start ASAP or will the start date be delayed?  ASAP

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Onsite at Mounds View site

Responsibilities may include the following and other duties may be assigned. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience
]]> Mon, 02 Feb 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required?  General quality experience in med device preferred; Design Assurance/Design Quality; self-driven, independent ability to engage with cross functional teams and manage project workload; Lean/six sigma project improvement experience

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Be the quality lead representative on global quality improvement, cost-down, and efficiency projects; engage in, review, and approve qualification deliverables, protocols, and processes; ensure products and quality processes maintain regulatory compliance while achieving cost down and efficiency targets

What products (if any) will this role support?  Quality team member for Global quality (GOSC) efficiency projects across multiple products

What is your target years of experience?  5-7 yrs depending on education and experience

 

___________________________________________________________________________________________________
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Fri, 23 Jan 2026 00:00:00 EST 1 In this exciting role as a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process
development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at the company's Tempe Campus.
 

1. What is the business title? Sr. Quality Engineer
2. Where is the work to be performed? (Please list preferred UHG facility, if other please specify i.e. remote work, rural, etc.) If hybrid, what is the onsite structure? On-site in Tempe, Arizona at the  Tempe Campus (MTC)
3. Can you please provide a summary of the project/initiative which describes what’s being done?  As a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at the company's Tempe Campus.  Initial scope of work may be focused on Inspection Optimization projects in addition to other duties supporting Quality in manufacturing operations of microelectronics assembly and IC and Wafer assembly.
4. What does the team make-up look like – how many members and what is the break-down of the team’s skill sets (ex: 1 PM, 4 Developers, etc.)?  Current team includes 5 Operations Quality Engineers and 2 Quality Technicians with varying levels of experience and skillset in the medical device field.
5. What are the top 5 responsibilities for this position? (Please be detailed as to what the candidate is expected to do or complete on a daily basis)

• Leading and managing Inspection Optimization projects that span different processes in our microelectronics assembly line.  Including both manual visual inspection and automated/semi-automated inspection methods.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, & OQPQ ensuring compliance and rigor.
• Partnering with process engineers on development of Test Methods and Test Method Validation plans and execution.  Spans both attribute and variables TMVs (Gage R&Rs/MSAs).
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.

What skills/attributes are a must have (Please be detailed as to number of years of experience)?

• Requires a Baccalaureate Engineering degree and minimum of 4 years of relevant experience OR Master's Engineering degree with a minimum of 2 years relevant experience
• Experience with general quality principles, procedures and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation.
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)

What skills/attributes are nice to have?

• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• Six Sigma or Lean Sigma belt certification
• Strong statistical analysis techniques & DOE design and execution
• Strong understanding of medical device manufacturing processes and products

A Day in the Life
Responsibilities may include the following and other duties may be assigned:
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. 
• Ensure internal quality processes, procedures and systems are compliant to all governing standards.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the
manufacturing team that enable high product quality via Process and Test Method Validations.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. 
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans andreports.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
• Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.
• Support CAPA investigations, improvements, and effectiveness verification testing
• Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. The Sr Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.
• Support and drive proper change control procedures and collaborate with change owners on their implementation
strategies and change documentation.
• Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and
projects simultaneously
• Communicate clearly regarding technical issues and solutions
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  TECHNICAL SKILLS
Must Have

• Experience with general quality principles, procedures and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation.
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)

Nice To Have

• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• Six Sigma or Lean Sigma belt certification
• Strong statistical analysis techniques & DOE design and execution
• Strong understanding of medical device manufacturing processes and products

]]> Fri, 23 Jan 2026 00:00:00 EST 1 Exciting Opportunity: Technology Transfer Engineer (Drug Substance) - County Louth 

Join Our Dynamic Technical Operations Team and Play a Key Role in Biopharmaceutical Innovation

We are seeking a highly motivated and experienced Technology Transfer Engineer to support our Drug Substance Manufacturing Science & Technology (MS&T) team. In this pivotal role, you'll contribute to the seamless transfer and optimization of biological drug manufacturing processes, ensuring the continued success and compliance of our global operations. This is a fantastic chance to be part of a fast-paced environment, working alongside industry-leading SMEs, and influencing critical phases of biological drug development and production.

What You’ll Bring to the Role

• Minimum of 3 years’ post-bachelor's experience in a GMP-related function such as Operations, Technical Support, Engineering, or Maintenance
• 2-3 years’ hands-on experience working with biological drug substances
• Proven ability to manage projects independently and meet deadlines
• Strong communication and team collaboration skills
• Knowledge of GMP documentation processes, change control, deviation management, and statistical process analysis

Additional Valuable Skills

• Experience in deviation management, equipment support, or process optimization projects
• Proficiency in statistics and continuous process verification
• Familiarity with regulatory inspections, GMP standards, and process validation practices

Preferred Education & Experience

• Bachelor’s degree in Life Sciences, Chemical Engineering, Biotech, or related fields
• Previous exposure to biologics manufacturing and tech transfer activities

Other Requirements

• Ability to work in a fast-changing project environment capturing surge activities planned for 2026

This role offers a 12-month contract, full-time hours (39 per week), and competitive pay aligned with industry standards. If you're motivated to contribute to cutting-edge biological manufacturing and thrive in a collaborative environment, we encourage you to apply now. Take the next step in your career and help shape the future of biopharmaceutical innovation!
]]> Wed, 12 Nov 2025 00:00:00 EST 1 Join Our Team as an EHS Project Engineer in County Louth – Drive Safety and Sustainability in a Cutting-Edge Pharmaceutical Environment

Are you a seasoned EHS professional with a passion for advancing safety standards in high-risk manufacturing settings? We are seeking two dedicated EHS Project Engineers to support innovative pharmaceutical projects. This strategic role offers the chance to make a meaningful impact on environmental health and safety initiatives within a leading industry operational hub. If you thrive in challenging environments, possess robust project management skills, and enjoy collaborating across functions, this opportunity could be your next career move.

What You’ll Bring:

• Minimum of 5 years’ experience in environmental health and safety within pharmaceutical, biotech, or medical device manufacturing sectors.
• Proven expertise supporting capital projects, facility upgrades, and equipment installations with a focus on EHS integration.
• Strong knowledge of GMP environments and cleanroom operations.
• Technical proficiency in construction safety, process safety management, chemical management, and hazard identification.
• Experience conducting risk assessments, PSSRs, incident investigations, and managing safety documentation.
• Excellent stakeholder engagement and communication skills to liaise effectively with diverse teams and regulatory bodies.

Additional Skills That Set You Apart:

• Certifications such as ATEX, Machinery, or Process Safety Management (PSM).
• Advanced degrees (MSc, MEng) in relevant disciplines.
• Knowledge of gas safety, hazard classification, and environmental permitting.
• Experience in GMP-regulated environments and supporting regulatory audits.

Preferred Education & Experience:

• Bachelor’s degree in Environmental, Chemical, or Occupational Safety Engineering, Industrial Hygiene, or related field.
• Advanced certifications and significant hands-on experience supporting complex manufacturing projects.

This is your chance to leverage your expertise in a dynamic, high-stakes environment that values safety and innovation. If you’re ready to contribute to a world-class pharmaceutical operation and help shape sustainable safety practices, we encourage you to apply now and take the next step in your career.
]]> Mon, 10 Nov 2025 00:00:00 EST 1 Senior Process Engineer based in County Carlow

Join a dynamic team as a Senior Process Engineer, where your expertise will drive innovative manufacturing processes and operational excellence. This pivotal role offers an exciting opportunity to contribute to cutting-edge projects within a collaborative environment, supporting the company's commitment to quality, efficiency, and continuous improvement. If you are a motivated professional with a passion for process engineering, this position is your chance to make a significant impact and advance your career.

Required Skills:

• Proven experience in process engineering within a manufacturing or industrial setting
• Strong analytical and problem-solving abilities
• Expertise in process optimization, lean manufacturing, or Six Sigma methodologies
• Excellent understanding of process control, automation, and equipment integration
• Effective communication skills and ability to work collaboratively across teams
• Proficient in relevant engineering software and tools

Nice to Have Skills:

• Knowledge of regulatory standards and compliance in manufacturing environments
• Experience with project management and process improvement initiatives
• Understanding of automation systems and advanced manufacturing technologies
• Prior experience working within a multidisciplinary engineering team

Preferred Education and Experience:

• Bachelor's degree or higher in Chemical, Mechanical, Process, or Industrial Engineering
• Minimum of 5 years' experience in a process engineering role, preferably within a similar industry

Other Requirements:

• Ability to liaise with and prepare documentation for relevant authorities

If you're ready to bring your expertise to a forward-thinking organization and thrive in a challenging yet rewarding environment, we encourage you to apply now. Take this opportunity to elevate your career and contribute to exciting projects in Carlow.
]]> Wed, 05 Nov 2025 00:00:00 EST 1