Sr. Manufacturing Engineer

Katalyst Healthcares and Life Sciences

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).

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Vacancy posted 3 days ago

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