Manager, Production Eng, Subs Value Strm

Johnson Johnson; Danvers (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Johnson & Johnson, Danvers, MA, is seeking a Production Engineering Manager to oversee technical support for production operations, drive process improvements, and mentor engineers. The role focuses on delivering daily schedules while reducing defects and enhancing product quality.

You will lead Lean Six Sigma initiatives, ensure regulatory compliance, and collaborate with Quality and other functions to implement CAPAs and process improvements.

Qualifications

• Strong analytical and problem-solving skills with data-driven decision-making.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Excellent communication across functions and leadership levels.

Responsibilities

• Lead, coach, and develop Production Engineers, managing performance and growth.
• Resolve manufacturing challenges through engineering expertise and data-driven methods.
• Ensure compliance with FDA QSR, ISO, GMP/GDP, and company policies.
• Drive CAPAs, nonconformance reduction, audit readiness, and corrective actions.
• Qualify and optimize manufacturing processes using IQ/OQ/PQ, SPC, DOE, and CP studies.
• Develop, maintain, and improve manufacturing documentation and workflows.

Skills

Analytical thinking

Problem solving

Leadership

Education

Bachelor's degree in engineering

Master's degree / MBA preferred

Tools

SAP

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 met 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, st