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) 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. **Qualifications / Requirements:** + 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. 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 interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Benchmarking, Coaching, Critical Thinking, Facility Management, Leading Change, Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Flow Management, Organizing, Performance Measurement, Predictive Maintenance, Product Design, Program Management, Project Schedule, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Strategic Thinking **The anticipated base pay range for this position is :** $100,000 - $172,500 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits