Katalyst Healthcares and Life Sciences
Engineer III - NPI Manufacturing
Katalyst Healthcares and Life Sciences, Andover, Massachusetts, us, 05544
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. Requirements:
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).
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. Requirements:
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).