Senior Advanced Manufacturing Engineer
Core
Lead process development, validation, scale up, and continuous improvement for Class I and Class II medical devices from New Product Introduction through commercialization.
Role type
Senior Advanced Manufacturing Engineer (Medical Devices)
Builds
Scalable, cost-effective production of high quality medical devices
Domain
Medical Devices / Regulated Manufacturing
Required skills
Manufacturing process development, Equipment qualification and validation (IQ/OQ/PQ), Process improvement (DMAIC), CAD (SolidWorks), Statistical analysis (Minitab), Design for manufacturability, Cleanroom operations
Preferred skills
Experience in regulated industries, Hands-on manufacturing support, Team leadership and mentoring
Technologies
SolidWorks, Minitab
Responsibilities
Develop and implement manufacturing processes and fixtures, Qualify and validate processes and equipment, Lead scale-up and capacity initiatives, Resolve production line issues, Support design changes for manufacturability, Ensure regulatory documentation compliance
Seniority
Senior, hands-on IC