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Senior NPI Engineer

Job in Danvers, Essex County, Massachusetts, 01923, USA
Listing for: 6942-ABIOMED Inc. Legal Entity
Full Time position
Listed on 2026-06-01
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer, Manufacturing Engineer
Salary/Wage Range or Industry Benchmark: 94000 - 151800 USD Yearly USD 94000.00 151800.00 YEAR
Job Description & How to Apply Below

Job Summary

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.
Qualifications – 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).
Qualifications – Preferred
  • 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.
Key Competencies
  • Technical authority & decision‑making
  • Influence & cross‑functional leadership
  • Advanced problem‑solving
  • Execution rigor & ownership
  • Risk management & quality compliance
  • Strategic thinking & scalability mindset
Equal Opportunity Employer

Johnson & 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.

Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us via  or contact AskGS to be directed to your accommodation resource.

Compensation & Benefits

The anticipated base pay range for this position is: $94,000 - $151,800. The position is eligible for an annual performance bonus and long‑term incentive program. Employee benefit programs include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a consolidated retirement plan (401k). Time‑off benefits include up to 120 hours of vacation per calendar year, 40 hours of sick time (up to 56 hours in Washington), up to 13 days of holiday pay (including floating holidays), and up to 40 hours of work, personal, and family time annually.

For additional general information on company benefits, visit

The job posting is anticipated to close on June 12, 2026. The company may extend this period; the posting remains available on  to accept additional applications.

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Position Requirements
10+ Years work experience
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