Senior Process Development Engineer
Core
Design and develop manufacturing processes for new disposable medical devices and ensure efficient transfer to production.
Role type
Senior Process Development Engineer
Builds
Manufacturing processes and equipment for disposable medical devices
Domain
Medical Devices / Manufacturing Engineering
Required skills
Process development, Design of Experiments (DOE), Six Sigma Black Belt, Process validation (IQ/OQ/PQ), Quality Systems (Design Control/CAPA), Technical documentation, Equipment characterization, Lean methodologies, Mistake proofing, Supplier coordination
Preferred skills
Medical device industry experience, Regulated industry experience
Technologies
Six Sigma, Lean, DOE, FMEA, BOM, Routers
Responsibilities
Develop and implement new manufacturing processes for disposable medical devices; Perform Design of Experiments to optimize equipment parameters; Create documentation to support new and improved manufacturing processes; Write and perform process validations (IQ, OQ, PQ/PPQ); Interface with assemblers, production supervisors, and management; Coordinate with suppliers for process/product plans; Assess process capabilities and implement improvements; Apply technical knowledge to design processes, procedures, tooling, and automation; Execute functional deliverables for PDP, Design Control, CAPA, and Quality Systems.
Seniority
Senior, hands-on IC