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Katalyst Healthcares & Life Sciences

Engineer III - NPI Manufacturing Job at Katalyst Healthcares & Life Sciences in

Katalyst Healthcares & Life Sciences, Andover, MA, US

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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).