Senior Npi Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

Senior NPI Engineer role focused on leading supplier and process engineering activities for new product introductions in the healthcare/medical device industry. Responsibilities include process development, validation, risk management, supplier qualification, and ensuring compliance with regulatory standards like FDA and ISO 13485. Requires strong experience in regulated environments and cross-functional leadership.

What you'd actually do

  1. Lead process development and industrialization for internal and external manufacturing processes.
  2. Own PFMEA, control plans, validation strategies, capability studies, and documentation.
  3. Conduct supplier capability assessments, gap analysis, and readiness reviews.
  4. Provide authoritative DFM/DFA/DFX guidance to R&D and program teams.
  5. Lead process validations (IQ/OQ/PQ), data analysis, and technical decision-making.

Skills

Required

  • 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 have

  • 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.

What the JD emphasized

  • FDA
  • ISO 13485
  • regulated environments
  • process validation
  • supplier qualification