https://CAREERS.PLANET-PHARMA.COM/ en-us Can you please confirm your top 3 skills sets required?

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

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

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

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

 
TECHNICAL SKILLS
Must Have

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

Nice To Have

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

 
Careers That Change Lives 

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

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

A Day in the Life 

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

 

Must Have: Minimum Requirements

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

 

Nice to Have

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

]]> Mon, 09 Mar 2026 00:00:00 EDT 1 Additional position details from the manager below:

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

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

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

DIFFERENTIATING FACTORS

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

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

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

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

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

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Mon, 09 Mar 2026 00:00:00 EDT 1 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.]]> Fri, 06 Mar 2026 00:00:00 EST 1 Fri, 06 Mar 2026 00:00:00 EST 1
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

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

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

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

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

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

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

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

Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience]]> Tue, 03 Mar 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required? 

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

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

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

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

When do you plan to start interviewing?? ASAP 

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

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

Job Responsibilities may include  

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

 
Position Overview: 

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

Key Responsibilities: 

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

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

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

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

• 
  Participate in design reviews for schematics and layout. 
  

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

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

Differentiating Factors: 

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

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

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

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

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

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

]]> Tue, 03 Mar 2026 00:00:00 EST 1 HM's Top Needs:

1. Ability handling blood (preferably in large volumes)
2. Basic wet lab skills
3. Proficiency in Microsoft Word and Excel

Education Required: High School Diploma, or Associate’s Degree (Bachelor’s degree would be overqualified and therefore, not be considered)

Years experience required: 1+ years

This position requires execution of duties in an animal/human blood lab using chemical, biological, electronic, mechanical, electromechanical and/or optical systems to assess the performance/interaction of medical devices with blood and/or equivalent test media in support of the development of new products and sustain the performance of released products. Responsibilities may include the following and other duties may be assigned. Performs a variety of technical procedures such as preparing routine solutions and reagents and performing routine reactions. Testing includes preparation of devices in perfusion circuits, circulating blood/test fluid through test circuits, and sampling blood/fluid at various time points. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation. Conducts laboratory support functions such as stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing labware. Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements. May analyze biological and chemical samples. Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental.

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

DIFFERENTIATING FACTORS

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

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

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

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

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

Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.
]]> Fri, 27 Feb 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required?

    Data driven problem solving

    Solid understand and application of regulatory requirements

    NCRs, Complaint Investigation, Site Transfers, Site Shutdowns

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

   Day to day sustaining operations quality support

   NCR Ownership

   Complaints DHR and manufacturing assessment

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

 

 
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Thu, 26 Feb 2026 00:00:00 EST 1
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, 19 Feb 2026 00:00:00 EST 0

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

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

Advanced Testing Knowledge

Packaging Testing
Nice To Have

• Basic laboratory mechanical testing skill
• Calibration

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

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

DIFFERENTIATING FACTORS

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

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

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

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

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

Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.]]> Wed, 18 Feb 2026 00:00:00 EST 1 POSITION SUMMARY:
The Coordinator 2, Quality Systems plays a key role in maintaining compliance and supporting the integrity of the company’s Quality Systems.
This position is responsible for ensuring GxP records are properly managed and accessible, while contributing to the effectiveness of core quality processes, specifically managing quality event processes and supporting complaint handling.
The role requires strong attention to detail, organizational skills, and the ability to collaborate across teams to uphold regulatory standards and company procedures.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Responsibilities may include, but are not limited to:
Administer and monitor quality event processes, ensuring conformance to standards, and track operational performance.
Sort and categorize records in alignment with retention schedules, regulatory requirements, and company procedures.
Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability.
Support complaint handling processes by accurately entering product complaint data into the system.
Assist with the maintenance and issuance of controlled logbooks.
Provide support across Quality System areas, including audits, CAPAs, document control, and training activities.
Perform additional duties as assigned to meet departmental and organizational objectives.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
High School Diploma (or equivalent) with 4+ years of experience in life sciences or medical device industry.
Strong foundation in records management and regulatory compliance.
Familiarity with MasterControl or similar Quality Management Systems.
Broad experience in Quality functions, including customer complaint processes.
Knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards.
Demonstrates integrity, self-confidence, and commitment to prioritizing customer and patient safety.
Excellent interpersonal skills; able to collaborate effectively across all organizational levels.
Strong work ethic with a proactive approach—eager to learn, take on new responsibilities, and seek additional tasks when available.

ENVIRONMENTAL CONDITIONS:
Physical Activities:
On a continuous basis, remain seated at a desk for extended periods of time; intermittently answer the telephone and type on a computer.
The role may also require periods of standing and walking, as well as lifting and carrying objects weighing up to 20–30 lbs.
The noise level in the work environment is usually low to moderate.
The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

TRAVEL:
No travel is required for this role.



Pay Rate Range: $25-28/hr depending on experience ]]> Tue, 10 Feb 2026 00:00:00 EST 1 Additional position details from the manager:
 

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

_______________________________________________________________________________________________

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

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

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

Responsibilities/ A Day in the Life

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

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

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

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

Nice to Have:  Preferred Requirements

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

• Familiar with statistical analysis tools such as Minitab or JMP

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

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

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

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

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

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

When do you plan to start interviewing?  ASAP

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

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

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

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

DIFFERENTIATING FACTORS

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

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

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

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

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

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

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

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

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

 

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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 This position will design and develop software for a medical instrument running iPad OS for clinical applications. Work will involve design and development of new code as well as debugging and refactoring of legacy code.  Candidate must be skilled in Objective C, C, JavaScript, multi-threading and event driven software.  Additionally, experience with CSS, HTML, XML and JSON and Cordova framework would be helpful

Must Have:

• 4+ years of relevant experience.
• Expertise in Objective C, C and JavaScript programming.
• Experience working with iOS/iPadOS and apple eco system
• Experience working in client/ server model and working across other interfaces
• Experience resolving multitasking, multithreading issues.
• Sound debugging skills using Xcode IDE
• Ability to work in an agile cross functional team environment
• Strong Communication skills.

Requires a University Degree and minimum 4 years of relevant experience, 

Nice to have (one or more):

• Experience with CSS, HTML, XML and JSON
• Experience with Cordova framework
• Experience with legacy code refactoring

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