Katalyst Healthcares & Life Sciences
Engineer III - NPI Manufacturing Job at Katalyst Healthcares & Life Sciences in
Katalyst Healthcares & Life Sciences, Andover, MA, US
Responsibilities:
- Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
- Participate in DFM and DFA activities to define manufacturing processes for new products and product enhancement programs.
- Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
- Bachelor's Degree at a Minimum.
- Only Candidates with a Medical Device Background.
- 5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
- Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
- Test Method Validation and Verification (TMV, V&V).