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Engineer, Test (Medical Device)

Fresenius Kabi USA, LLC
$73,360 - $84,900
life insurance, 401(k)
United States, Massachusetts, North Andover
50 High Street (Show on map)
Apr 07, 2025
Job Summary The Engineer, Test (Medical Device) assists with all phases of systems performance verification and validation activities for infusion devices to support product development, product changes, and regulatory submissions. This includes prototype evaluations, planning, and execution of informal and formal verification cycles and reporting.

Salary Range:$73,360 - $84,900
*Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
*Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here. Responsibilities
  • Performs formal Verification and Validation activities using high precision equipment and data collection software tools.
  • Collaborates with R&D and Test team members to develop and write clear test procedures and data capture methods for verification of performance specifications.
  • Work with R&D and Test Team to understand the impact assessment of changes and determine the appropriate test strategy.
  • Develop test fixtures and methods.
  • Train and provide guidance on day-to-day activities for Test Technicians.
  • Conducts investigatory testing - compiles and reports results.
  • Enters defects and verification information into defect tracking tool.
  • Assists with the purchase and management of lab supplies and equipment.
  • Demonstrates proficient technical writing and analytical skills.

Requirements

- Bachelor's degree in Engineering (Mechanical, Computer, Biomedical or related) or equivalent experience

- Minimum 1 year of work expereince

- Knowledge of electro-mechanical medical device and software testing
- Exceptional analytical and technical writing skills
- Knowledge of quality systems and medical device standards
- Ability to work in a laboratory environment
- Self-motivated, curious, and detail-oriented team member with proven critical thinking skills

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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