Sr NPI Engineer
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for Sr. NPI Engineer. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Requirements
- 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).
Nice To Haves
- 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.
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.
Benefits
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401k).
- This position is eligible to participate in the Company’s long-term incentive program.
- Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year.
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
- Holiday pay, including Floating Holidays – up to 13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
