What are the responsibilities and job description for the Sr. Manufacturing Engineer position at Katalyst CRO?
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
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.
- 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).