Principal Production Engineer

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 MedTech, 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. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About Cardiovascular

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 https://www.jnj.com/medtech

We are searching for the best talent for Principal Production Engineer in Danvers, MA.

Purpose: This role provides strategic and hands-on technical leadership across manufacturing operations for complex electro-mechanical medical devices used in life-saving cardiac support therapies. This role owns scale-up, process validation, root-cause investigations, safety, regulatory compliance, and continuous improvement initiatives. You will mentor engineers, partner across R&D, Quality, Regulatory, and Supply Chain, and drive cost savings and performance improvements at a site or multi-site level.

You will be responsible for:

• Strategic Leadership & Technical Vision

• • Define and drive the manufacturing strategy and technology roadmap for scale-up, capital projects, and process automation.

  • Lead critical programs from concept through commercialization, ensuring alignment with regulatory, quality, and business goals.

• Scale-Up & Design/Process Transfer

• • Own scale-up from pilot/early production to full-scale manufacturing; manage design transfer activities with cross-functional teams.

  • Develop robust manufacturing readiness plans, including process mapping, equipment qualification, and line layout optimization.

• Validation, Qualification & Qualification Life Cycle

• • Lead IQ/OQ/PQ strategies for equipment, processes, packaging, and software where applicable.

  • Develop validation protocols, execute plans, analyze results, and secure sign-off; ensure traceability to user needs and regulatory requirements.

• Root Cause Investigation & CAPA

• • Champion structured problem solving for yield issues, quality escapes, and process deviations.

  • Drive CAPA execution, verify effectiveness, and close with data-backed evidence and sustainability.

• Safety, Quality & Regulatory Compliance

• • Maintain alignment with regulatory expectations (e.g., FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as needed.

• Process Improvement & Cost Optimization

• • Lead Lean/Six Sigma initiatives to improve throughput, reduce cycle times, increase yield, and lower cost per unit.

  • Apply DOE, SPC, MSA, Cp/Cpk analyses and other advanced analytics to optimize processes and sustain gains.

• Data, Metrics & Decision Support

• • Define and track KPIs (yield, scrap rate, OEE, CAPA closure, cycle time) an