Principal Production Engineer

Principal Production Engineer – Johnson & Johnson Med Tech

Location: Danvers, MA, United States

Job Function: Supply Chain Engineering
• Manufacturing Engineering

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. The Principal Production Engineer will lead scale‑up, process validation, root‑cause investigations, safety, regulatory compliance, and continuous improvement initiatives while mentoring engineers and partnering across R&D, Quality, Regulatory, and Supply Chain to drive cost savings and performance improvements at a site or multi‑site level.

• 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 & Life‑Cycle Management
  • 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) and provide actionable insights to leadership.
  • Develop dashboards and storytelling visuals to communicate program status and risks.
• Cross‑Functional Collaboration & People Development
  • Partner with Quality, Regulatory, R&D, Supply Chain, and Operations to align on milestones, risks, and resource needs.
  • Mentor and coach engineers and technicians; foster a culture of continuous improvement and knowledge sharing.

• Bachelor’s degree in Mechanical, Industrial, Biomedical, or related Engineering;
  Master’s degree or equivalent experience preferred.
• 10+ years in manufacturing engineering or operations within medical devices or complex product environments.
• Deep understanding of FDA QSR/21 CFR Part 820 and ISO 13485.
• Experience with design controls, design transfer, validation activities, and quality systems in a regulated setting.
• Proficient in DOE, SPC, MSA, Cp/Cpk, PFMEA, Control Plans, and CAPA management.
• Knowledge of manufacturing processes (e.g., plastics, polymers, adhesives, molding, assembly, packaging, sterilization) as relevant to the product line.
• Experience with change control, CAPA, PFMEA, control plans, and documentation management.
• Excellent problem‑solving, communication, and project‑management skills.
• Demonstrated ability to lead large‑scale programs and mentor diverse teams.

Pay range: $100,000 – $172,500 annually.

The position is eligible for company‑sponsored benefit programs including medical, dental, vision, life insurance, disability, accident insurance, legal insurance, pension/401(k), and long‑term incentive program. Eligible employees also receive paid vacation, sick time, holiday pay, parental leave, caregiver leave, and other time‑off benefits as detailed in the company benefit plan.

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 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.

If you are an individual with a disability and would like to request an accommodation, please contact the J&J career portal at