有源医疗器械工艺工程师
Core
Process engineering for active medical devices, focusing on new product introduction, localization, and production process validation at a dialysis manufacturing plant.
Role type
Process Engineer (Active Medical Devices)
Builds
Dialyzers, bloodline sets, dialysis solutions, hemodialysis machines, and medical components
Domain
Medical Devices / Renal Care / Manufacturing
Required skills
New Product Introduction (NPI), Process Creation, Process Validation, SOP Development, Quality Control, 5S Management, Equipment Operation, Troubleshooting, CAPA, Design Transfer
Technologies
Injection Molding, Extrusion, Automated Assembly
Responsibilities
Lead NPI and localization projects, define production concepts and equipment, create process documents (SOP, Flow Chart, DHR), execute process validation, manage 5S and WIP, operate and troubleshoot manufacturing equipment, optimize production efficiency and safety, investigate customer complaints and CAPA, handle design transfer
Seniority
Mid-level, hands-on IC