Principal Mechanical Engineer
Core
Lead the design, development, and transfer of significant new medical device products, resolving complex technical issues and directing new technology initiatives.
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), resource planning, budget management, cross-functional leadership, mentoring
Preferred skills
Complex engineering calculations, statistical analysis, tolerance analysis, Design for Manufacture (DFM), low-cost high-volume disposable product design, GxP knowledge
Technologies
None explicitly listed
Responsibilities
Specify, design, verify, and validate new mechanical designs per medical regulatory standards; Lead development of product specifications, FMEAs, DOEs, and V&V protocols; Manage engineering project plans, schedules, and budgets; Provide technical guidance and mentoring to the mechanical engineering team; Act as independent reviewer on programs not directly involved; Ensure product designs meet all applicable standards and regulations.
Seniority
Principal, hands-on IC with strategic direction