Sr NPI Engineer
Core
Leading supplier and process engineering activities for new product introductions in cardiovascular medical devices, ensuring robust industrialization, supplier readiness, and flawless design transfer.
Role type
Senior NPI Engineer (Supplier & Process Engineering)
Builds
New cardiovascular medical device products (heart recovery, electrophysiology, stroke solutions)
Domain
Medical Device / Cardiovascular / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development and industrialization, PFMEA and control plans, supplier capability assessment, DFM/DFA/DFX guidance, process validation (IQ/OQ/PQ), PPAP deliverables, risk management and mitigation, statistical data analysis (DOE, MSA, SPC), cross-functional leadership
Preferred skills
PPAP/APQP experience, micro-assembly and joining technologies, Lean manufacturing or Six Sigma certification, CAD tools proficiency, project management basics
Technologies
Minitab, JMP, CAD tools
Responsibilities
Lead process development and industrialization for internal and external manufacturing processes, Own PFMEA, control plans, validation strategies, and capability studies, Conduct supplier capability assessments and readiness reviews, Provide DFM/DFA/DFX guidance to R&D and program teams, Lead process validations (IQ/OQ/PQ) and technical decision-making, Drive PPAP deliverables and tooling readiness, Partner with R&D, Regulatory, Operations, and Quality for design transfer, Identify risks and define mitigation actions for compliance, Lead structured problem-solving for supplier or process failures, Support cost, yield, and scalability improvements, Mentor junior and experienced engineers
Seniority
Senior, hands-on IC with mentorship responsibilities