Senior NPI Engineer
Listed on 2026-05-18
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Engineering
Quality Engineering, Process Engineer
Senior NPI Engineer (Supplier & Process Engineering)
We are searching for the best talent for Sr. NPI Engineer. The Senior NPI Engineer leads supplier and process engineering activities for new product introductions. This role drives robust industrialization, ensures supplier readiness, and owns process validation and risk management activities. The Senior NPI Engineer influences design decisions, leads cross‑functional alignment, and ensures flawless design transfer and launch readiness.
Key Responsibilities- Lead process development and industrialization for internal and external manufacturing processes.
- Own PFMEA, control plans, validation strategies, capability studies, and documentation.
- Conduct supplier capability assessments, gap analysis, and readiness reviews.
- Provide authoritative DFM/DFA/DFX guidance to R&D and program teams.
- Lead process validations (IQ/OQ/PQ), data analysis, and technical decision‑making.
- Drive PPAP deliverables, supplier qualification, and tooling readiness.
- Partner with R&D, Regulatory, Operations, and Quality to ensure seamless design transfer.
- Identify risks, define mitigation actions, and ensure compliance with FDA, ISO 13485, and internal quality systems.
- Lead structured problem‑solving (DMAIC, 8D, root cause analysis) for supplier or process failures.
- Support cost, yield, and scalability improvements throughout the NPI lifecycle.
- Represent the function in program leadership meetings and provide readiness updates to management.
- Bachelor’s degree in Mechanical, Industrial, Electrical, Biomedical, or related engineering field.
- 7–10+ years of experience in NPI, Supplier Engineering, Manufacturing Engineering, or Process Engineering.
- Demonstrated expertise in DFX, PFMEA, process validation, and supplier qualification.
- Strong experience in regulated environments (medical device strongly preferred).
- Proven ability to lead cross‑functional initiatives and influence technical decisions.
- Strong data analysis and statistical skills (DOE, MSA, SPC).
- Experience with PPAP/APQP and complex supplier ecosystems.
- Background in micro‑assembly, catheter manufacturing, machining, electronics, or automated processes.
- Six Sigma Green Belt or Black Belt certification.
- Experience mentoring junior engineers.
- Technical authority & decision‑making
- Influence & cross‑functional leadership
- Advanced problem‑solving
- Execution rigor & ownership
- Risk management & quality compliance
- Strategic thinking & scalability mindset
The anticipated base pay range for this position is: $94,000 - $151,800. The Company offers performance‑based compensation including an annual performance bonus. Eligible employees may participate in benefits such as medical, dental, vision, life insurance, disability, and retirement plans. Additional benefits include vacation, sick time, holiday pay, and long‑term incentive programs.
Equal Opportunity EmployerJohnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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