Principal Production Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 were 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 thats 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 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:

• Bachelors degree in Mechanical Industrial Biomedical or related Engineering; Masters 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 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 :

$100000 - $172500

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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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. Experience:

Staff IC