Description
The role leads the development, optimization, and validation of medical device manufacturing processes, including IQ/OQ/PQ, DOE, FMEA, SPC, and ISO/GMP compliance. It manages technical documentation, cross-functional sustaining engineering projects, tooling and automation improvements, APQP and EO/DCN changes, KPIs, cost models, corrective actions, and training. The position requires a bachelor's degree in engineering or a related technical field and 5–8+ years of experience in regulated contract manufacturing for medical devices.
