Biomedical Engineer – In-Vitro Test Systems

• We are seeking a Biomedical Engineer to join an in-vitro testing team supporting the development and qualification of a next-generation test system. This role will focus on replacing an existing legacy test setup with a new, higher-capacity system while incorporating new test methods and ensuring robust validation.
• The ideal candidate will have hands-on experience with test system development, test method validation, CAD design, and statistical analysis, along with the ability to work collaboratively in an R&D laboratory environment.

• Support the design and development of a new in-vitro test system to replace an existing legacy system.
• Help develop a test setup that provides increased testing capacity, efficiency, and functionality compared with the existing system.
• Integrate new test methods into the new test system and associated testing procedures.
• Support the qualification of the new test system to ensure it meets applicable performance and testing requirements.
• Plan and execute test method validation activities, including measurement system analysis (MSA) and Gage R&R studies.
• Develop, modify, and interpret CAD drawings and models related to test-system components and setups.
• Conduct testing, analyze test results, identify issues, and support troubleshooting of the test system.
• Use statistical analysis to evaluate test performance, repeatability, reproducibility, and measurement-system capability.
• Document test methods, validation activities, results, and conclusions in accordance with applicable R&D and quality procedures.
• Collaborate with engineers and cross-functional team members to implement improvements and support development-testing needs.

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related engineering discipline.
• Experience with test method development and/or test system development.
• Experience performing test method validation and measurement system analysis.
• Working knowledge of Gage R&R and other MSA techniques.
• Experience interpreting and creating CAD drawings.
• Strong analytical and problem-solving skills.
• Ability to work effectively in an R&D laboratory and hands-on testing environment.

• Solid Works or comparable CAD software.
• JMP, Minitab, or comparable statistical analysis software.
• Statistical analysis and interpretation of experimental test data.
• Test system qualification and validation methodologies.
• Measurement System Analysis (MSA).
• Gage R&R.

• Experience developing or improving laboratory or in-vitro test systems.
• Experience supporting medical device, biomedical, life sciences, or other regulated-product R&D.
• Experience transitioning or replacing legacy test equipment and systems.
• Familiarity with engineering documentation, test protocols, and validation reports.
• Experience troubleshooting test-system hardware and procedures.

This is an excellent opportunity for a Biomedical Engineer with strong test development, validation, CAD, and statistical analysis experience to contribute to the development of an upgraded in-vitro testing capability and support R&D engineering initiatives.