Manager, Production Eng, Subs Value Strm

6942-ABIOMED Inc. Legal Entity; Danvers (MA); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson in Danvers, Massachusetts is seeking a Production Engineering Manager to oversee manufacturing operations, drive process improvements, and mentor a team of Production Engineers. The role blends engineering rigor with leadership to advance cardiovascular manufacturing capabilities.

You will apply Lean Six Sigma, validate processes, manage CAPAs with Quality, and ensure compliance with FDA QSR, ISO, GMP/GDP; strong communication and cross-functional collaboration are essential

Qualifications

• Strong knowledge of FDA QSR, ISO standards, and applicable regulatory requirements.
• Strong analytical and problem-solving skills with experience using Lean Manufacturing, Six Sigma, Kaizen, statistical tools, and data-driven decision-making to improve manufacturing processes and performance.
• Six Sigma Black Belt preferred.
• Strong verbal and written communication skills with the ability to collaborate across functions and organizational levels.
• Demonstrated ability to exercise sound technical judgment and independently solve complex manufacturing and process-related challenges.
• Proficiency with Microsoft Office applications; SAP experience preferred.

Responsibilities

• Lead, coach, and develop Production Engineers by assigning work, managing performance, and fostering technical growth and continuous improvement.
• Anticipate and resolve manufacturing challenges through engineering expertise, data-driven decision-making, and industry best practices.
• Ensure compliance with all quality, regulatory, health, safety, environmental (HSE), and company requirements, including FDA QSR, ISO standards, GMP/GDP, and applicable policies and procedures.
• Partner with Quality to drive CAPAs, nonconformance reduction, audit readiness, investigations, and timely implementation of corrective actions.
• Qualify, optimize, and monitor manufacturing processes using validation activities (IQ/OQ/PQ), statistical tools, SPC, DOE, Gage R&R, and process capability studies.
• Establish, monitor, and improve key performance indicators (KPIs) such as safety, quality, yield, productivity, and equipment uptime.
• Lead continuous improvement initiatives using Lean Six Sigma principles, evaluating resource requirements, ROI, and implementation timelines.
• Support production operations, process transfers, and global collaboration to ensure business objectives are achieved on time.
• Develop, maintain, and improve manufacturing documentation, including work instructions, procedures, BOMs, process flows, routers, travelers, and PFMEAs.
• Plan and execute engineering projects, managing schedules, budgets, resources, and deliverables aligned with business goals.
• Communicate risks, issues, and opportunities to leadership and key stakeholders in a timely manner.
• Perform other duties as assigned.

Skills

Lean Six Sigma

Data-driven decision making

Problem solving

Leadership

Communication

Education

Bachelor’s degree in engineering

Master’s degree or MBA preferred

Tools

SAP

Microsoft Office

Job description

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 jnj.com. 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.

Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: People Leader All Job Posting Locations: Danvers, Massachusetts, United States of America

Job Description: We are searching for the best talent for Manager, Production Engineering. 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.

JOB SUMMARY

The Production Engineering Manager will oversee the technical support of production operations, improvement and validation of manufacturing processes, tooling, and fixtures in order to meet daily production schedules, while mentoring team members, reducing defects and enhancing productivity and product quality.

DUTIES & RESPONSIBILITIES

• Lead, coach, and develop Production Engineers by assigning work, managing performance, and fostering technical growth and continuous improvement.
• Anticipate and resolve manufacturing challenges through engineering expertise, data-driven decision-making, and industry best practices.
• Ensure compliance with all quality, regulatory, health, safety, environmental (HSE), and company requirements, including FDA QSR, ISO standards, GMP/GDP, and applicable policies and procedures.
• Partner with Quality to drive CAPAs, nonconformance reduction, audit readiness, investigations, and timely implementation of corrective actions.
• Qualify, optimize, and monitor manufacturing processes using validation activities (IQ/OQ/PQ), statistical tools, SPC, DOE, Gage R&R, and process capability studies.
• Establish, monitor, and improve key performance indicators (KPIs) such as safety, quality, yield, productivity, and equipment uptime.
• Lead continuous improvement initiatives using Lean Six Sigma principles, evaluating resource requirements, ROI, and implementation timelines.
• Support production operations, process transfers, and global collaboration to ensure business objectives are achieved on time.
• Develop, maintain, and improve manufacturing documentation, including work instructions, procedures, BOMs, process flows, routers, travelers, and PFMEAs.
• Plan and execute engineering projects, managing schedules, budgets, resources, and deliverables aligned with business goals.
• Communicate risks, issues, and opportunities to leadership and key stakeholders in a timely manner.
• Perform other duties as assigned.

EXPERIENCE AND EDUCATION

Bachelor’s degree in engineering required; Master’s degree or MBA preferred. Equivalent combination of education and experience will be considered. 6+ years of manufacturing experience, preferably in the medical device industry and/or cleanroom environment. Demonstrated leadership, people management, or complex project management experience preferred.

REQUIRED KNOWLEDGE & SKILLS

Strong knowledge of FDA QSR, ISO standards, and applicable regulatory requirements. Strong analytical and problem-solving skills with experience using Lean Manufacturing, Six Sigma, Kaizen, statistical tools, and data-driven decision-making to improve manufacturing processes and performance. Six Sigma Black Belt preferred. Strong verbal and written communication skills with the ability to effectively collaborate across functions and organizational levels. Demonstrated ability to exercise sound technical judgment and independently solve complex manufacturing and process-related challenges. Proficiency with Microsoft Office applications; SAP experience preferred.

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $102,000-177,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

EMPLOYEE BENEFITS

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs:
  • medical
  • dental
  • vision
  • life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401k).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year.
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year.
  • Work, Personal and Family Time - up to 40 hours per calendar year.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on August 20,2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson: Changing health for humanity

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/.