Sr Npi Engineer

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $94,000 - $151,800; bonus/equity: eligible f...
Not specified
Process development and industrialization
Pfmea and control plans
Supplier capability assessments
Johnson & Johnson is seeking a Senior NPI Engineer to lead process development and industrialization within their Cardiovascular team in Danvers, Massachusetts. The ideal candidate will have extensive experience in NPI and process engineering, specifically within regulated environments, to drive innovation in healthcare solutions

Job Summary

  • Lead process development and industrialization for internal and external manufacturing processes, owning PFMEA, control plans, validation strategies, and documentation.
  • Conduct supplier capability assessments, gap analysis, and readiness reviews, providing authoritative DFM/DFA/DFX guidance to R&D and program teams.
  • Partner with R&D, Regulatory, Operations, and Quality to ensure seamless design transfer and identify risks, define mitigation actions, and ensure compliance with FDA, ISO 13485, and internal quality systems.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior NPI Engineer to lead process development and industrialization within their Cardiovascular team in Danvers, Massachusetts. The ideal candidate will have extensive experience in NPI and process engineering, specifically within regulated environments, to drive innovation in healthcare solutions.

Salary

Base: $94,000 - $151,800; Bonus/Equity: Eligible for annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, 401k, long-term incentive program

Skills & Requirements

Must-have

  • Process development and industrialization
  • PFMEA and control plans
  • Supplier capability assessments
  • DFM/DFA/DFX guidance
  • Process validation (IQ/OQ/PQ)
  • Structured problem-solving (DMAIC, 8D)

Nice-to-have

  • Passion for cardiovascular innovation
  • Reimagining how we heal
  • Inclusive work environment
  • Respect for diversity and dignity

Key Requirements

  • Bachelor's degree in engineering
  • 7-10+ years of experience
  • Expertise in DFX, PFMEA, process validation
  • Experience in regulated environments
  • Ability to lead cross-functional initiatives
  • Strong data analysis and statistical skills

Work Rights

Not specified

Tailored Resume

Cover Letter