Sr Npi Engineer

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

This role focuses on New Product Introduction (NPI) engineering within the healthcare domain, specifically in process engineering and supplier readiness for medical devices. It involves leading process development, validation, risk management, and ensuring compliance with regulatory standards like FDA and ISO 13485. The role 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)
  • Business Fluent English

Nice to have

  • Master’s degree
  • Experience with PPAP/APQP and complex supplier ecosystems
  • Background in micro‑assembly, joining technologies, injection molding, catheter manufacturing, machining, electronics, or automated processes
  • Lean manufacturing or Six Sigma certification (Green Belt or higher)
  • Experience in mentoring junior engineers
  • Proficiency with CAD tools, statistical analysis software (e.g., Minitab, JMP)
  • Basics of project management
  • Business fluent german

What the JD emphasized

  • regulated environments
  • FDA
  • ISO 13485