Production Engineering Manager – Medical Devices

jj; Danvers (MA); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Vacation 120 hours per year

Job summary

The Production Engineering Manager at Johnson & Johnson will oversee the technical support of production operations, drive process validation and continuous improvement, and mentor a team of Production Engineers to meet daily schedules while enhancing quality and productivity.

You will ensure compliance with FDA QSR, ISO, GMP/GDP, and lead Lean Six Sigma initiatives, partnering with Quality and global teams to optimize manufacturing processes and documentation.

Qualifications

• 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.

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

FDA QSR

ISO standards

Regulatory requirements

Lean Manufacturing

Six Sigma

Kaizen

Data-driven decision-making

SAP experience

Microsoft Office

Verbal and written communication

Education

Bachelor’s degree in engineering

Master’s degree or MBA preferred

Tools

SAP

Microsoft Office

Job description

The Production Engineering Manager at Johnson & Johnson will oversee the technical support of production operations, drive process validation and continuous improvement, and mentor a team of Production Engineers to meet daily schedules while enhancing quality and productivity.

You will ensure compliance with FDA QSR, ISO, GMP/GDP, and lead Lean Six Sigma initiatives, partnering with Quality and global teams to optimize manufacturing processes and documentation.