Process Development Engineer
Core
Develop, validate, and industrialize manufacturing processes for new medical device products at external contract manufacturers and suppliers.
Role type
Process Development Engineer (Medical Devices)
Builds
Manufacturing processes and industrialization plans for new product introductions
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process characterization, Design of Experiments (DOE), statistical analysis, manufacturing process validation (IQ/OQ/PQ), supplier technical execution, industrialization planning, risk assessment
Preferred skills
Catheter-based or minimally invasive device experience, extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, packaging, DFM, PFMEA, APQP, PPAP, Minitab, JMP
Responsibilities
Lead development of manufacturing processes at external suppliers for new product introduction programs; Design and execute process characterization studies, DOE, and statistical analyses; Develop and coordinate manufacturing industrialization plans; Drive supplier technical execution by leading reviews and resolving issues; Create and maintain validation and manufacturing documentation
Seniority
Mid-Senior, hands-on IC
