Staff NPI Engineer
Core
Lead New Product Introduction (NPI) programs, equipment qualification, and process validation to ensure manufacturing readiness and operational performance for medical devices.
Role type
Staff NPI Engineer (Medical Device Manufacturing)
Builds
New medical device products and manufacturing processes
Domain
Medical Devices / Insulin Delivery Systems
Required skills
Project management, Equipment qualification (IQ/OQ/PQ), Process validation, Risk management (PFMEA), cGMP compliance, Structured problem-solving (DMAIC/Six Sigma), Cross-functional leadership, Engineering documentation
Preferred skills
Mechanical/Electrical/Industrial engineering background, High-volume cleanroom experience, Fast-paced manufacturing environment adaptability, Decision-making under risk
Technologies
FDA 21 CFR Part 820, ISO 13485, PFMEA, DMAIC, Six Sigma
Responsibilities
Lead NPI programs from concept to production ramp-up; Execute equipment qualification and process validation; Collaborate with Operations, Quality, and R&D; Drive continuous improvement and CAPA; Maintain cGMP compliance; Author engineering documentation.
Seniority
Staff, technical leadership & mentoring