https://CAREERS.PLANET-PHARMA.COM/ en-us Can you please confirm your top 3 skills sets required?  Production support, communication, production transfer, critical thinking  

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Production Support, Product transfer, Process validation

What products (if any) will this role support?  Cryo-Ablation Probes

What is your target years of experience?  1-5 years of experience

 
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. 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. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

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]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Additional position details from the manager:

Can you please confirm your top 3 skills sets required? Experience running project schedules using MS Project or similar software, experience with project risk management, excellent communication

Can you please confirm the 3 main responsibilities/day to day activities required for this role? Cross-functional project schedule development and management, leading risk management activities, leading meetings and communicating across the team and project sponsors

What products (if any) will this role support? PVH released products and/or new product development

What is your target years of experience? 7-10 years

_____________________________________________________________________________________________________
 

Within our Research & Development organization in Peripheral Vascular Health, we focus on deploying project management methodologies and practices to ensure robust planning, monitoring/controlling and execution of new product development activities, continuous improvement initiatives and released product management. Our Project Management Specialists are directly involved in all stages of the project life cycle for our innovative devices and therapies.

 

In this role, the individual will work on projects that are in various phases of product development. They will be working with internal project team members as well as suppliers and business partners to develop and sustain our product portfolio. As a core team member, this individual will be responsible for defining the scope, budget, and timeline of the project, along with managing project execution within a cross-functional team. This position requires broad cross-functional knowledge and comprehensive business management skills, working closely with team members with expertise from the following disciplines: product development, clinical, regulatory affairs, quality, operations, supplier quality and product marketing.

 

A Day in the Life:

 

·         Represent the Research & Development Portfolio Operations group on teams as the PMO representative

·         Build cross functional project schedules from first principles.

·         Identify and escalate project risks and issues.

·         Lead project management activities such as project planning, tracking, risk management, and communications. 

·         Implement best practice tools and techniques in project management within projects and within PVH R&D.

·         Track and monitor project performance and progress and provide regular updates to stakeholders

·         Manage changing priorities on projects through effective schedule management and deployment of PM methodologies.

·         Keep the Team Leader and key Sponsors and Stakeholders informed of capacity constraints and portfolio risks.

·         Act as a role model by striving for continuous improvement and being an agent of change.

·         Support continuous improvement initiatives within the PMO.

 

Nice to Have

• Experience working in Technical Project Management environment

• Experience with medical device design control is desirable.

• Cross-functional team 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 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1
Job Description:
• Responsible for maintenance and repair of all building support equipment/systems including HVAC, boilers, electrical, emergency power and plumbing in a FDA regulated industry.
• Responsible for preventative maintenance and repair of laboratory equipment including autoclaves, RO/DI water system, incubators, temperature/humidity chambers, refrigerators, freezers, exhaust fans, clean rooms, laminar airflow hoods, and biological safety cabinets.
• Completes/troubleshoots unscheduled repairs of building and laboratory equipment
• Coordinates contractors and ensures completion of all tasks
• Picks up parts and supplies at local vendors.
• Assists in all phases of assigned project work including planning, scheduling, acquiring materials, and scheduling contractors. Completes project within budget and on time.
• Responds to emergency calls after scheduled working hours, weekends, and holidays.
• Assists in training.

Qualifications & Technical Competencies:
*Experience in an industry GxP setting strongly preferred 
•    High school diploma or GED required.  Associate’s degree and/or equivalent industry/trade training (e.g. apprenticeship program) preferred.
•    Minimum 5 - 7 years of related maintenance experience required
•    Knowledge of Siemens Building Automation System and Square D Lighting System.
•    Working knowledge of building renovation including framing, drywall, wiring, building codes, computer/phone cabling, T-Bar suspension ceiling and painting.
 ]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Can you please confirm your top 3 skills sets required?

1. 1. Hardware Engineering: Strong foundation in electrical hardware design, hardware characterization, bench testing, troubleshooting, and debug
   2. AI Tool Development and Utilization: Ability to develop, adapt, and apply AI-enabled tools to improve engineering design, development, analysis, and test workflows.
   3. PCB Design and Circuit Modeling: Experience with PCB design, schematic capture, circuit simulation, and modeling to support robust hardware development.
   4. Formal test planning, execution, and documentation in medical device or similarly regulated industry

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

1. 1. Execute hardware test, characterization, and debug activities to support electrical design development, integration, and issue resolution.
   2. Develop and drive formal characterization and verification efforts, including test planning, execution, data analysis, and documentation.
   3. Implement and apply AI-enabled tools and workflows to accelerate engineering design, development, test, analysis, and documentation activities.
   4. Experience with AI in hardware development such as embedded intelligence, edge AI, or AI-enabled hardware systems is a strong plus.

What products (if any) will this role support?  Cardiac implantable devices such as implantable monitors, pacemakers, and/or implantable defibrillators

What is your target years of experience?  3+ years of relevant experience in electrical hardware engineering, including design, characterization, testing, debug, and integration.  1+ years of experience applying automation, scripting, AI tools, or AI-enabled workflows to engineering development, analysis, or test activities is preferred.

When do you plan to start interviewing?  April

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
__________________________________________________________________________________________________________________________

Responsibilities may include the following and other duties may be assigned.
Researches, develops, designs, integrates, and tests electrical components, equipment, systems, and networks for medical devices and related platforms. Designs electrical hardware, assemblies, PCBAs, power architectures, sensing and acquisition circuits, embedded hardware, and system-level electrical interfaces for regulated products. Applies strong systems engineering discipline across requirements development, architecture, design, risk management, integration, verification, validation, and design transfer. Leverages AI-enabled engineering tools to improve engineering productivity, quality, and decision-making in areas such as requirements analysis, documentation generation, data analysis, test development, failure investigation, and workflow automation. Uses practical experience with AI/ML concepts to support electrical and hardware development, including edge or embedded AI, real-time inference considerations, model optimization for constrained compute, and hardware/software co-design. Creates and improves automated methods for engineering tasks related to functional expertise, including test automation, data reduction, reporting, and design process efficiency. Partners cross-functionally with systems, software, mechanical, quality, manufacturing, regulatory, and supplier teams to deliver robust, compliant, and scalable solutions. This is a contract position supporting the Electrical Systems Design Group.

SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty spanning electrical systems design, electrical hardware development, and AI-enabled engineering methods for medical devices. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or direct the work of lower-level professionals. The majority of time is spent delivering and overseeing projects from design through implementation while adhering to policies, quality system requirements, and specialized knowledge and skills normally acquired through advanced education and relevant industry experience.

DIFFERENTIATING FACTORS

Autonomy:
Recognized technical specialist, managing medium to large projects or processes. Exercises considerable latitude in determining deliverables, methods, tools, and technical approaches, with limited oversight from manager. Makes sound engineering decisions across electrical architecture, hardware design, integration, verification, and use of AI tools for engineering workflows. Coaches, reviews, and delegates work to lower-level specialists when appropriate.

Organizational Impact:
Contributes to defining the direction for new products, processes, technical standards, and operational plans based on business strategy, with significant impact on work group results. Helps shape how AI-enabled tools and automation are adopted within the Electrical Systems Design Group to improve speed, consistency, traceability, and design quality. May manage large projects or processes that span outside the immediate job area.

Innovation and Complexity:
Problems and issues faced are difficult, moderately complex, and often undefined, requiring detailed information gathering, analysis, and investigation. Develops solutions to moderately complex problems and/or makes moderate to significant improvements to processes, systems, or products independently to enhance performance of the job area. Applies engineering judgment to balance safety, reliability, performance, manufacturability, compliance, and schedule. Evaluates and implements practical AI/ML approaches for engineering and hardware use cases, including workflow automation, analysis of large datasets, model-assisted engineering, and deployment considerations such as latency, local compute limits, quantization, distillation, model size, and real-time behavior.

Communication and Influence:
Represents the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers, suppliers, and vendors at various levels. Communicates complex electrical systems, hardware, and AI-related concepts clearly and effectively to technical and non-technical stakeholders. May negotiate with others to reach understanding or agreement, and influence decision-making related to architecture, risk, verification strategy, supplier engagement, and engineering tool adoption.

Leadership and Talent Management:
Typically provides guidance, coaching, and training to other team members within the job area. Typically leads major or moderately complex projects involving delegation of work and review of work products, at times acting as a technical team leader. In a contract capacity, is expected to provide strong technical leadership, elevate team capability, and share best practices in electrical systems development, AI tool utilization, and engineering automation.

Required Knowledge and Experience:
Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. Must have strong experience in electrical hardware and electrical systems development for medical devices, including system architecture, analog and digital design, power and signal integrity, embedded hardware, integration, bench testing, and root-cause analysis. Must have practical experience using AI tools to improve engineering output and automating functionally relevant workflows through scripting, data analysis, test automation, requirements support, documentation generation, or similar applications. Experience with AI/ML for hardware-related use cases is strongly preferred, including edge or embedded AI, real-time inference on constrained hardware, model optimization, quantization, distillation, hardware/software co-design, and evaluation of AI performance in production-like environments. Working knowledge of design controls, risk management, verification and validation, and regulated product development is required; familiarity with standards and frameworks such as IEC 60601, ISO 13485, and FDA-regulated development environments is preferred. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.
]]> Thu, 09 Apr 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.

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Remote
 
HM's Top Needs:

1. CCI CRAT or CCT certified

2. IBHRE Pacemaker/ICD experience 3 years +

3. Medical device or cardiac experience 2+ years
 

Education Required:

 Bachelor's degree in Health Sciences, Biology or a related field preferred.

Years’ Experience Required:

2-5 years related work experience required in cardiac monitoring and analysis.

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

40 hours per week with the possibility to flex to less if experience was right

The Assoc Clinical Data Specialist (Cardiac Technician) Identifies normal and abnormal findings during basic device EGM or ECG reviews and analyze data form patient devices using knowledge and understanding of diagnostic and therapeutic procedures. Works with scientists and research members to accurately label and use findings for AI development, clinical studies and research protocols

Essential Responsibilities:

1.      Identifies normal and abnormal findings during basic device interrogations, ECGs or EGMs. This includes ICM’s, pacemakers, ICDs, and cardiac resynchronization devices.

2.      Reviews and analyze data with research groups and clinical data team of findings to help assist research members in study protocols

 
Responsibilities:

- Review Cardiac Implantable Electronic Device data and provide quality analysis of the data and accurate annotation review

- Collaborates with various departments on annotation and understanding annotation review and implementation of annotation labels for purposes of AI development

- Delivers annotation projects assigned and works with other stakeholders to achieve desired results. 

- The majority of time is spent delivering implantable device EGM/ECG annotation review and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

 

NICE TO HAVES:

-          IBHRE/CCI RCES or 2-5 years minimum of EGM annotation experience

-          ECG Annotation experience minimum 2-5 years

 

MUST HAVES

-          Education Required: Bachelors Degree

-          Years’ Experience Required: 2 -5 years minimum.

-          CCI CRAT/CCT
 

Role Hours and Location: 40 hours per week. Flexibility in hours is allowed after 4-6 week training period. Role is 100% Remote. Hybrid is available if requested
]]> Wed, 08 Apr 2026 00:00:00 EDT 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, 08 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?

?Systems engineering, medical device design, strong written/verbal skills
 

Nice To Have

• neuromodulation, experience with system modeling, interface design, working with standards and regulations, strong verbal and written skills

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

?Reviewing and authoring technical documentation (including requirements and design implementation), cross-                     functional collaboration, managing/prioritizing tasks and workload alongside project schedules

What products (if any) will this role support?

??Pelvic health - tibial neuromodulation 

What is your target years of experience?

?3-8 years

 

Responsibilities may include the following and other duties may be assigned. Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

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, 08 Apr 2026 00:00:00 EDT 1

Can you please confirm your top 3 skills sets required?  System Integration Experience, System Verification Experience, EE or ME or SW degree.

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Develop Tests, Execute Tests, Identify Issues with the product (failed tests)

What products (if any) will this role support?  Medtronic Spinal Cord Systems – Patient Instruments, Implantable Stimulators, and External Stimulators

What is your target years of experience?  5-10

When do you plan to start interviewing?  Early April

Will you be looking to hire and start ASAP or will the start date be delayed?  Starting First Week of May 2026.

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Both, at least 4 days a week onsite.
_____________________________________________________________________________________________
Responsibilities may include the following and other duties may be assigned. Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications. 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, 08 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?

#1 – I’m looking an engineer who doesn’t feel they must be doing hardcore research and development to provide high value.  Looking for someone that is capable and interested in solving problems and achieving results, whether or not the problem statement is highly technical.

#2 - Engineering design change management/documentation in a regulated environment.

#3 – Recent demonstrated capability in basic engineering skills such circuit schematic design/comprehension and benchtop electrical testing with various lab equipment.

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

#1 – Performing product failure analysis.

#2 – Processing engineering change records in Agile and Windchill.

#3 – Taking work direction from senior engineering staff to satisfy various engineering tasks as needed.

What products (if any) will this role support?  CRM market released Instruments (non-implanted medical devices) such as pacemaker programmers, home monitors, patient assistants, and temporary external pacemakers.

What is your target years of experience?  Open to 0-5 years of experience with a target of 2-3.



This position is for a junior to mid level electrical engineer to provide assistance to the CRM Instruments HW Released Product Engineering group (a.k.a. continuation engineering, sustaining engineering, product support).  This group participates in several cross functional teams for market released external medical instrumentation products. Cross functional project teams include members from Product Development, Manufacturing, Marketing, Sourcing, Contract Manufacturing Engineering, Quality, Reliability, and Regulatory functions. The group’s primary objective is to provide the design expertise necessary to support continuity of quality and compliant products.  This electrical engineer will be taking work direction from the engineers on staff to fulfill various technical and documentation responsibilities.

**Position Responsibilities:

* Assess supplier driven changes, component changes, and component obsolescence for potential impact against product functional requirements and document the testing required or rationale (analysis) for no testing.

* Create test plans and reports, and coordinate product testing.

* Evaluate returned product to determine the root cause of field returns and establish design improvements.

* Create and implement engineering changes in the Product Data Management system. This includes leading the cross functional change review and approval process.

* Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.

* Provide technical expertise to support electrical and mechanical projects that expand the capabilities of existing product and system solutions.

* Review and analyze circuit schematics and technical component specifications.

* Design, simulate, and test analog and digital circuits either independently or while working closely with a design technician for the development of improved solutions and evaluation of returned product.

* Generate high quality formal documentation and records.

* Manage, configure, track, verify, and transport test samples.

* Assess the impact of changing regulatory standards on existing medical products and assess the impact of changes in medical products against existing regulatory standards.

* Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved quickly to assure quality and continuity of supply.  Some issues requiring resolution may contain a mechanical element as well. Leverage area expertise and learn new design elements to quickly become the design expert as issues require.

**Required Qualifications:

* 0 to 5 years industry experience

* Bachelor of Electrical Engineering or another Engineering with a very strong focus in electronics

* Must have the capability of functioning independently as an Electrical Engineer with minimal supervision

* Skills include analog/digital circuit design and troubleshooting, laboratory practices, circuit simulation, product testing, and design of experiments

* Demonstrated problem solving skills

* Strong written communication skills

* Proven experience working effectively both independently and with multi-functional teams.

**Desired Qualifications:

* Experience in a regulated industry (e.g. medical, aerospace, military).

* Experience in the development or support of medical products

* Experience with evolving technology such as USB, Bluetooth, mobile (cellular) technology, and WiFi

* Experience in manufacturing or post market support

* General understanding of how to interpret and apply industry recognized standards, especially for medical electronic products

* Strong verbal skills

* Experience with quick turn assignments
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

1. Can you please confirm your top 3 skills sets required?
   1. Portfolio-wide strategy/planning for post-market product maintenance. We receive inputs on product changes from across the org, and we need to plan the timing/order of incorporating these changes into the finished goods/eManuals to support global distribution while avoiding stockouts, meeting regulatory and compliance deadlines, expediting safety-related changes, etc. Strategic thinking and planning is important.
   2. Effective program leadership in a regulated environment plus a matrixed organization. We lead teams that are dispersed across multiple sites, working in different environments. Need to be effective at planning schedules, leading teams, meeting facilitation, risk management, project management, partnering with other project managers across the org, etc.
   3. Communications, progress monitoring, and reporting. Ownership of project budgets (financial planning, monitoring, and reporting), product release roadmaps (timelines for changes and new product releases across the portfolio), monthly progress reporting (to leadership, with peers / cross-functional leaders, etc.)
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Project intake & Release Planning (gathering inputs on detailed changes, thinking through and documenting the strategy for implementing changes in final pack / eManuals to meet deadlines and minimize frequency of changes)
   2. Monitoring and controlling in-process release projects (leading the core release team, manufacturing site team, translations team, etc.)
   3. Maintaining effective communication (release roadmaps, schedules, release plans, proforma/budget tracker, etc.)
3. What products (if any) will this role support?
   1. This position will support across all Neuromodulation and Pelvic Health products, but with a focus on TDD.
4. What is your target years of experience?
   1. Four years of work experience plus Bachelor’s degree, at least two years of Project Management experience
5. When do you plan to start interviewing?
   1. Within the next two weeks
6. Will you be looking to hire and start ASAP or will the start date be delayed? 
   1. Start beginning of May, if we can make that happen.
7. Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?
   1. On site 4 days per week. Can work remotely on Fridays.

______________________________________________________________________________________________

The Product Release Program Lead is responsible for leading, establishing, and driving execution of product release cadences for the Neuromodulation and Pelvic Health (NMPH) portfolio of products. Projects within scope will include but are not limited to: Release Product Engineering (RPE), CAPAs, Sustaining Engineering, and New Product Introduction. This position requires broad cross-functional knowledge and comprehensive business management skills. 

 

A Day in the Life

·         Accountable for overall project execution. Including: project planning, budgeting, schedule creation, and execution.

·         Establishes product release strategy through multiple project inputs, establishing operational plans and execution.

·         Leads and manages site-specific and cross-functional teams established with the purpose of successfully accomplishing the objectives of the product release program.

·         Monitors progress toward pre-established objectives, assesses risks, and implements strategies to ensure successful program execution.

·         Directs the work of site-specific and cross-functions through a matrix organization.

·         Secures site-specific and cross-functional commitments, maintaining milestones and budget. Deploys team resources to meet project/program objectives.

·         Maintains effective communication and interface with various leadership teams.

·         Ensure effective project transition relevant to development, quality, manufacturing, distribution, regulatory, and commercial entities.

·         Provides input to Functional Managers on team member performance, as needed.

·         Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.

·         Develops mechanisms for monitoring and reporting project progress and for intervention and problem solving with project managers, line managers, and clients.

·         Ensures the project/program complies with all aspects of the quality policy/system.

·         Ensure appropriate departmental resources are assigned to the program/project and are available to effectively maintain the quality system (people, facilities, tools, and training).

·         Problems and issues faced can be complex, difficult and undefined, requiring detailed information gathering, analysis and investigation to understand the problem.

·         Other responsibilities, as required and assigned.

 

Must Haves

·         Bachelor’s degree with 4+ years of job-related experience -OR- Master’s degree with 2+ years of job-related experience

·         2+ years of project management experience

 

Nice to Haves

·         2+ years coordinating manufacturing site activities.

·         5+ years in medical device product development, or other highly regulated environment.

·         Project Management Professional (PMP) certified.

·         Experience working with FDA, ISO, EN, and/or GMP standards.

·         Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.

·         Excellent downward, lateral, and upward communication skills.

·         Good balance of high level strategic and detailed tactical thought processes.

·         Demonstrated track record of successfully leading projects/programs to completion.
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Target Pay Rate: 40-53/hr **salary will be commensurate with experience 

Summary
In the Systems Engineer role, you will be supporting the overall technical direction of Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. Tasks may include product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

What you'll be doing:
• Perform the activities associated with the systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance
• Understand clinical and user needs and apply them to product realization
• Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.
• Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective
• Craft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area
• Create and maintain design history file elements
• Facilitate an improved understanding of the interrelationship between requirements, risk and reliability
• Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results
• Resolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.
• Propose and drive solutions to technical problems that are ambiguous and diverse in scope
• Perform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. As needed, propose recommended mitigations with rationale.
• Influence stakeholders and cross-functional team members within the project
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
• Use various software tools and programs to complete the above responsibilities

What you'll bring:
• Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains
• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• A track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military
• Prior experience with internet-connected, software-enabled devices and/or cyber security
• Working knowledge of system modeling language (SysML or UML) and requirement management tools
• Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Success in working with multi-functional, global teams
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders
• Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
• Ability to deliver results according to the plan

Experience and/or Background:
• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Three or more years of relevant experience]]> Wed, 08 Apr 2026 00:00:00 EDT 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.]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

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

This role will be project focused, working with Program management and other engineers to perform root cause analysis and investigation tasks towards optimizing and implementing improvements within both production and pre-production environments. This role will be required to define optimization opportunities based on engineering findings, present to the team, and implement showing improvements within the manufacturing yield/process.

What products (if any) will this role support?

This role will have the opportunity to support products built for pharmaceutical operations (combination steroid/medical device products) and/or Cardiac Surgery.

What is your target years of experience?

Looking for E2 position equivalent. Target years of experience falls within 2-3 years within the medical device manufacturing or development engineering fields. 

When do you plan to start interviewing?  ASAP 

Will you be looking to hire and start ASAP or will the start date be delayed?  Hiring process will be focused on a start date of early to mid Q1 FY27. 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Full-time onsite (4+ days)

_______________________________________________________________________________________________________________

Relevant experience in process development deliverables (IQ, OQ, PQ), process characterization work, and equipment development experience is preferred.

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

• Provide technical and sustaining engineering support within a manufacturing environment.
• Recommend and implement equipment and process modifications to meet quality standards, improve production efficiencies, enhance manufacturing techniques, and increase yields for existing products.
• Integrate equipment and material capabilities to meet process module and technology target specifications.
• Review product development requirements for compatibility with processing methods and provide input on cost and schedule implications.
• Collaborate with product design and development teams to ensure processes and designs are aligned and manufacturable.
• Perform or support statistical analysis and contribute to documentation improvements when needed.
• Lead innovation, development, and optimization of new manufacturing concepts, processes, and procedures for transfer into manufacturing operations, including feasibility assessments, material selection, equipment selection, tooling and fixture development, and evaluation of process inputs and outputs.
• Develop manufacturing processes suitable for statistical process control and support development of measurement systems. Ensure all processes and procedures comply with regulatory requirements.

]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Must Have

Experience with multiple 3D printing technologies and materials (i.e. setting up jobs and running jobs, troubleshooting failures, post-processing parts, etc.)

High school diploma or equivalent

CAD expertise (e.g. Solidworks)

Mechanical aptitude

Demonstrated experience designing parts/assemblies/systems that provide a range of solutions and outcomes

Demonstrated ability to work and collaborate with customers of various backgrounds and needs

Demonstrated ability to work under timelines

Strong communication skills

Demonstrated ability to work well both autonomously and as a member of a cohesive team

Demonstrated high quality standards with great attention to detail

Strong desire to collaborate with others to solve problems

Strong ability to manage and prioritize time

8+ years of relevant experience

 

Nice to Have

Experience working at a medical device company

Toolmaking experience

Familiarity with the following 3D printing technologies: FDM, FFF, SLA, DLP, Polyjet, Binder Jetting, MJF, Metal

 
]]> Tue, 07 Apr 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.]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Senior Software Safety Engineer
As a Senior Software Safety Engineer, you’ll play a critical role in designing and shaping cutting-edge cardiac rhythm management products that improve patient outcomes worldwide.  Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. We are comprised of three businesses:  Cardiac Pacing Therapies, Cardiovascular Diagnostics & Services and Defibrillation Solutions.
This is your chance to collaborate with diverse, cross-functional teams—including product development, software reliability, cybersecurity, human research development, medical safety, and regulatory bodies—to ensure our products meet the highest safety and performance standards. Your expertise will directly influence the development, production, and market release of life-saving technologies.
In this exciting role, you’ll:

• 
  Identify and mitigate patient safety hazards within company software, working closely with cross functional teams.
  
• 
  Ensure risk management files are meticulously developed and maintained in compliance with ISO 13485, ISO 14971, and IEC 62304 standards, while providing critical feedback during the design input and output phases.
  
• 
  Lead efforts to trace design validation and verification in risk management files, ensuring every safety measure aligns with global standards.
  

• 
  Recommend innovative risk mitigations and deliver data-driven risk-versus-benefit analyses to project stakeholders, always keeping patient safety as the top priority.
  
• 
  Design and develop reusable patterns and encourage innovation that will increase team velocity.
  

This position is in Mounds View, MN within the Cardiac Rhythm Management (CRM) unit.   We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
In general, the following responsibilities apply for the Senior Software Safety Engineer role. This includes, but is not limited to the following:

• 
  Collaborates with cross-functional teams to develop and release new cardiac rhythm management software products and design changes.
  
• 
  Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.
  
• 
  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/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives. 
  
• 
  Develops, coordinates and conducts technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. 
  
• 
  Recommends and develops design or test methods and statistical process control procedures for achieving required levels of product reliability and safety. 
  
• 
  Proposes changes in design or formulation to improve system and/or process reliability and product safety. 
  

Qualifications - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• 
  Bachelor’s degree in engineering, math, science or technical discipline and minimum of 4+ years of work experience in engineering and/or quality OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality.
  

Nice to Have

• 
  Advanced degree in engineering or science.
  
• 
  Proven understanding of product reliability/safety engineering principles.
  
• 
  Experience in a highly regulated industry, preferably implantable medical devices. 
  
• 
  Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. 
  
• 
  Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HAL, FTA, DFMEA). 
  
• 
  Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
  
• 
  Experience in design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
  
• 
  Working knowledge of artificial intelligence (AI) tools.
  
• 
  Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.
  
• 
  Proficiency in two or more of the following technologies: C++, Java, JavaScript, HTML, C#, .NET, Python, Angular, Xamarin.
  

]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Pay 40-50/h depending on experience

HM's Top Needs:

1. Medical device regulatory experience in change assessment with focus on US FDA and EU MDR

2. Experience with medical device manufacturing process changes and design changes

3. Experience with US (510k, LTF, Deciding when to submit…) and EU (change notifications with Notified Bodies)

 

Education Required: Bachelors

Years’ Experience Required: 3-5 years

 

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

Work Location:

                Do they need to be local to any MDT office and if so where? Yes, MA, CT, CO, MN… other MDT sites considered

Does this person need to be on site? If so, full time or part time?  Yes, full time



Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

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, 02 Apr 2026 00:00:00 EDT 1 *depending on exp

About This Role:
This is an exciting opportunity for a talented individual to join a small team supporting a growing medical device startup. We are currently seeking a highly motivated and detail-oriented individual to join our team as a Product Builder. As a Product Builder, you will play a crucial role in the manufacturing process, ensuring the highest quality standards are met for our products. In all actions, this person shall demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Your Responsibilities Will Include:
• Assemble and build orthopedic implants and instruments according to established procedures and specifications.
• Perform quality checks and inspections to ensure products meet the required standards.
• Maintain a clean and organized work area to ensure efficient workflow and adherence to safety protocols.
• Collaborate with cross-functional teams to troubleshoot and resolve any manufacturing issues.
• Follow all company policies and procedures to ensure compliance with regulatory requirements.
• Contribute to process improvement initiatives to enhance productivity and product quality.
• Meet production targets and deadlines while maintaining a high level of accuracy and attention to detail.


Minimum Qualifications
• High school diploma or equivalent; technical or vocational training in a related field is preferred.
• Proven experience in a manufacturing or assembly role, preferably in the medical device industry.
• Strong manual dexterity and ability to work with small tools and components.
• Excellent attention to detail and ability to follow precise instructions.
• Basic understanding of quality control principles and practices.
• Ability to work effectively in a team environment and collaborate with colleagues.
• Commitment to maintaining a high level of integrity and professionalism.


Preferred Qualifications:
• Prior experience in orthopedic implant manufacturing or medical device assembly.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing.
• Familiarity with Lean Manufacturing principles and continuous improvement methodologies.


Other
• Ability to lift up to 20 pounds
• Ability to wear clean room clothing and work in a cleanroom environment]]> Mon, 30 Mar 2026 00:00:00 EDT 1 Must Have

• Human Factors Validation - Study Design, Protocol, and Report
• use-related risk analysis
• User Testing - Generative, Formative, Summative

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

Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products. Develops and implements research methodologies to test and evaluate developmental prototypes used in all phases of products development and processes. Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users. Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

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, 30 Mar 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?  Production support, communication, critical thinking

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Day-to-day production floor support, NCMR processing, CAPA processing

What products (if any) will this role support?  Mechanical Heart Valves

What is your target years of experience?  1-5 years of experience

 
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. 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. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

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]]> Fri, 27 Mar 2026 00:00:00 EDT 1 Additional position details from the manager:

1. Can you please confirm your top 3 skills sets required?
   1. Proficiency and experience in developing and debugging C# code or other OOP languages.
   2. Experience with the development and execution of automated testing using automated test software language.
   3. Experience with the programming and the operation of electrical lab equipment such as oscilloscopes, power supplies, waveform generators, network analyzers, etc….
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Develop software for automated tests to communicate with medical devices and test equipment
   2. Perform Test Method Validation and Document Test Procedures
   3. Execute automated tests and summarize test data for review by Design Engineers.
3. What products (if any) will this role support? Various Cardiac Rhythm Management implantable products (Pacemakers, Defibrillators, Recorders)
4. What is your target years of experience? 4 years but flexible for the right candidate
5. When do you plan to start interviewing? I would do an informal phone/Teams interview as soon as I think I have a potential candidate
6. Will you be looking to hire and start ASAP or will the start date be delayed?  This will be a FY27 hire so the earliest start date will be the beginning of FY27
7. Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Fully onsite

In this role you will develop and execute electrical hardware automated tests related to the design and development of implantable cardiac medical devices. You will work closely with Design Engineers to understand product requirements and develop tests for those requirements. You will be expected to work independently and with minimal supervision.  Responsibilities may include the following and other duties may be assigned.

• Develop software for automated tests to communicate with medical devices and test equipment
• Perform Test Method Validation and Document Test Procedures
• Execute automated tests and summarize test data for review by Design Engineers.
• Communicate status of testing to Technicians, Test Engineers, Design Engineers, or Program Managers
• Ensure understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance.

Must Have: Minimum Requirements 

• Proficiency and experience in developing and debugging C# code or other OOP languages.
• Experience with the development and execution of automated testing using automated test software language.
• Experience with the programming and the operation of electrical lab equipment such as oscilloscopes, power supplies, waveform generators, network analyzers, etc….
• Ability to work onsite 5 days a week
• Strong troubleshooting skills

 Nice to Have: Preferred Requirements

• Experience working in a regulated industry, preferably medical devices
• Experience in writing test documentation
• Knowledge of Circuit Boards, electrical components, and Electrical Engineering basics
• Experience with Various Communication Protocols (RS-232, RS-485, GPIB, TCP/IP, Ether CAT, EtherNet/IP, etc.)
• Experience with C and/or C++
• Experience using Reflection in C#
• Experience with Python
• Experience with LabVIEW
• Strong interpersonal skills
• Strong written and verbal communication skills
• Strong attention to detail
• Demonstrated ability to work in cross functional teams
• Demonstrated ability to work with embedded systems
• Experience with performing Verification and Validation in a regulated industry

]]> Thu, 26 Mar 2026 00:00:00 EDT 1 HM's Top Needs:
1.  experience related to the management and negotiation of the Patient Informed Consent, specifically within the US

2.  document management and ability to follow standard operating procedures and appropriate document management (ensuring key stakeholders are engaged, documents are uploaded to the trial master file, all while ensuring quality of the content)

3.  relationship management and ability to work with diverse teams (study team, functional team, site research team)

 

Education Required: Bachelor’s degree, ideally in Clinical Research, Biology or Chemistry, and a

Years’ Experience Required: minimum of 2 years of experience working on consent/Informed Consent (IC)/contracts within clinical research


Responsibilities may include the following and other duties may be assigned. Administers, extends, negotiates and terminates standard and nonstandard contracts. Conducts proposal preparation, contract negotiation, contract administration, and customer contact activities to provide for proper contract acquisition and fulfillment in accordance with company policies, legal requirements, and customer specifications. Examines estimates of material, equipment services, production costs, performance requirements, and delivery schedules to ensure accuracy and completeness. Prepares bids, processes specifications, progress, and other reports; advises management of contractual rights and obligations; compiles and analyzes data and maintains historical information. 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.
]]> Thu, 26 Mar 2026 00:00:00 EDT 1 Additional position details from the manager:

Can you please confirm your top 3 skills sets required?

1. Follow written guidance
   2. Willingness to learn and function on a team
   3. Some test experience, electrical testing a plus

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



The primary focus of this position will be Mechanical & Electrical testing of CRM and NEURO division’s products. This may include packaging testing, mechanical, and electrical testing of leads, pacemakers, defibrillators, loop recorders. Testing is focused on subjecting our devices to a wide variety of exposures (environmental, fatigue, implant procedures, electrical, electromagnetic) and ensuring designs are robust and meet specifications. Responsibilities may include the following and other duties may be assigned.

• Ensure conformance to test plans, work instructions, and industry standards for execution and use of drop, shock and vibe systems, environmental chambers, Instron, electrical test systems and equipment, multimeters, generators, oscilloscopes, etc.
• Prepare, set up, troubleshoot, and utilize test instrumentation and complex test set-ups.
• Plan test schedules to manage priorities, maximize equipment run time, and technician time.
• Communicate with management and customers on the estimated start date, status of work in progress, issues, observations, potential disruptions, and competing priorities.
• Work effectively and efficiently in a team environment and as an individual.
• Lead and collaborate on projects, including performing complex tests and providing updates to the broader teams and/or customers.
• Proficiency with computer skills, Microsoft Word and Excel for data collection and documenting processes.
• Proficient in adhering to industry, company, and department policies.
• Ability to read and follow all processes related to testing.
• Good communication, interpersonal and technical writing skills; communicate and document results clearly and accurately.
• Participate in internal and external audits.
• Work is 100% onsite in facility located in Fridley, MN
• On rare occasions, perform offsite testing which may occur overnight or weekends.
• HS Diploma/GED required

Ideal Candidate will:

•  2+ years testing background on medical devices a plus but not required
•  Completed vocational or technical education
•  Motivated to learn, work, and be part of a high functioning team
•   Work as a team member and support multiple projects and responsibilities
•   Pay close adherence to work instructions, policies, procedures, and good documentation practices
•   Knowledge of FDA regulations and ISO/IEC 17025, as well as working in a regulated environment
•   Mechanical, Electrical, and EMC testing experience
•   Demonstrate safe work practices, for example ICD handling and high voltage tests
•   Solder and assembly experience
•   Familiar with calibration and metrology services and support
•   Working knowledge of Test Method Validations / Install Qualifications

]]> Wed, 25 Mar 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required?

• At least 3 years of experience with ISO 14971 in a medical device company
• At least 3 years of experience creating or maintaining risk management files for medical devices
• At least 3 years of experience working with Quality Design Control deliverables

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

• Updating and Maintaining Risk Management Files for Class III Medical Devices
• Working with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Collaborating with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

What products (if any) will this role support?

• Spinal Chord Stimulation, Deep Brain Stimulation, Pelvic Health

What is your target years of experience?

• At least 5 years of experience within Medical Device

When do you plan to start interviewing?

• As soon as possible

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

• Targeted starting date: May 4, 2026. 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?

• 4 days a week onsite and 1 day remote

____________________________________________________________________________________________

We are currently looking for a  Sr  Risk Engineer to work within the Neuromodulation and Pelvic Health to drive the and support risk management sustaining activities. 

Location: This position will be a an onsite role  in Fridley, Minnesota with the benefit of working remotely on Fridays.

In this critical role as Sr. Risk Management Engineer, you will work closely with multidisciplinary project teams to create, and remediate risk management documents that meet ISO 14971 . This role is people oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail.

 Responsibilities may include but are not limited to:

·        Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.

·        Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

·         Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.

·         Evaluate impact of potential issues to patient safety and product performance

·         Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.

·         Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle.

·         Identify and act upon opportunities for continuous improvement of the Risk Management Process

·         Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance.

·         Create documentation in compliance with applicable procedures to meet project deliverables.

Qualifications 

Experience with implantable medical devices.

Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).

Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).

Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.

Experience in the application of statistics.

Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.

Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.

Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.
]]> Wed, 25 Mar 2026 00:00:00 EDT 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. 
  

]]> Fri, 20 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?
   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]]> Wed, 11 Mar 2026 00:00:00 EDT 1 Analyzes, develops, and implements long-term supply chain strategies and networks that address capacity issues and production location decisions in support of business goals.
Supports business execution of new programs and initiatives that include promotional activities, forecast and coordination for key events, new product launches, and network redesigns.
Monitors key sales and operations planning performance indicators, cost-to-serve performance data, and coordinates cross-functional work teams to increase effectiveness of supply chain initiatives.
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.
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 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 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.]]> Tue, 10 Mar 2026 00:00:00 EDT 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 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