Principal Mechanical Engineer
Core
Lead the design, development, and transfer of significant new medical device products, resolving complex technical issues and driving technology implementation.
Role type
Principal Mechanical Engineer (Product Development)
Builds
New medical device products and manufacturing processes
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features
Required skills
Mechanical design, new product development, design transfer, project management, technical supervision, regulatory compliance (FDA/ISO), cross-functional leadership, resource planning, budget management, FMEA, DOE, verification and validation protocols
Preferred skills
Complex engineering calculations, statistical analysis, tolerance analysis, equipment commissioning, design for manufacture of high-volume disposable products, GxP knowledge
Technologies
None explicitly stated
Responsibilities
Specify, design, verify, and validate new mechanical designs; lead development of product specifications and validation protocols; manage project plans, schedules, and budgets; act as independent reviewer on programs; provide mentoring and technical guidance to the engineering team
Seniority
Principal, hands-on IC with strategic direction