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Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences is hiring: Sr. Manufacturing Engineer in Wa

Katalyst Healthcares & Life Sciences, Warsaw, IN, US

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Summary:
We're looking for a Sr. Manufacturing Engineer to lead and execute CNC equipment/process validation in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability, this is a strong opportunity.

Roles and Responsibilities:
  • Lead validation for CNC machines (mills, lathes, multi-axis) and tooling/work holding.
  • Author and maintain IQ/OQ/PQ protocols & reports + validation documentation.
  • Support Master Validation Plans, FMEA/risk assessments, and change controls.
  • Execute calibration, metrology, and Gage R&R; ensure full traceability.
  • Perform data analysis and capability studies (Cp/Cpk, Minitab/JMP).
  • Close deviations, support CAPAs/nonconformances, and maintain audit readiness.
  • Support supplier qualification/acceptance testing and operator training.
Education and Qualifications:
  • BS in Mechanical/Manufacturing/Biomedical Engineering (or related).
  • 3–7 years in CNC manufacturing + validation in regulated environments.
  • Strong knowledge of ISO 13485, GMP, 21 CFR Part 820 (ISO 14971 preferred).
  • Experience with eQMS tools (e.g., MasterControl, ETQ).