Senior NPI Engineer- Mechanical

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 Med Tech, 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.

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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.

Supply Chain Engineering

Process Engineering

Scientific/Technology

All Job Posting Locations:
Danvers, Massachusetts, United States of America

We are searching for the best talent for Senior NPI Engineer - Mechanical. 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

• Serve as the primary technical contact and manufacturing engineering liaison between internal product development teams and external suppliers/contract manufacturers.
• Collaborate with design teams to provide DfX (manufacturing, assembly) feedback for system enclosures, plastic and sheet metal parts.
• Create, validate, and document manufacturing processes, tooling, and fixtures for new products mechanical sub-assemblies working with external manufacturing partners/supplier.
• Partner with R&D and suppliers to conduct risk assessments (FMEAs) and create process validation and qualification plans (MVP, IQ/OQ/PQ) for supplier execution.
• Prepare assembly instructions, BOMs, and process documentation.
• Support incoming inspection teams as a technical expert to troubleshoot mechanical assemblies and system build failures during the NPI phase.

• Bachelors degree required (masters degree preferred) in mechanical engineering or related fields.
• At least 5+ years of experience as a mechanical design/test engineer in NPI role, preferably with a systems background in robotics, automotive, or medical device.
• Pro in CAD software (e.g., Solid Works, Catea, Fusion
  360), FEA analysis, and GD&T.
• Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports required. Experience designing and executing Gauge R&R studies preferred.
• Working with suppliers and EMS/CM partners highly preferred.
• Strong leadership, cross-functional communication, and proactive problem-solving.
• Knowledge of FDA 21
  
  CFR
  820/821 and ISO 13485 requirements.
• Working knowledge of SAP a plus.
• Willingness to travel within US and International 10-15% of the time.

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 under 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 interview process that is inclusive of our applicants’ needs. 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…