Senior Manufacturing Process Engineer
Core
Develop new manufacturing processes, equipment, and materials for medical device production, focusing on process optimization, validation, and design control in an FDA-regulated environment.
Role type
Senior Manufacturing Process Engineer
Builds
Medical device production lines and validated manufacturing processes
Domain
Healthcare / Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering, Design of Experiments (DOE), Failure Mode and Effects Analysis (pFMEA), Statistical analysis, Tolerance analysis, Engineering calculations, Design control procedures, FDA/GxP/ISO regulations knowledge, Cross-functional collaboration
Preferred skills
Mechanical or Chemical engineering background, Experience with low-cost high-volume product design, Diabetes strip manufacturing knowledge
Technologies
FDA guidelines, ISO13485, ISO134851, GxP
Responsibilities
Specify, design, verify, and validate new manufacturing processes and equipment; Troubleshoot process equipment and perform process optimization; Develop process/product specifications and validation protocols; Conduct technical design reviews; Write and submit Engineering Change Orders; Maintain effectiveness of the quality system.
Seniority
Senior, hands-on IC
