Lead Production Engineer - MedTech & Cardio Devices

Johnson & Johnson MedTech; Danvers (MA); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

Life insurance

Disability coverage

401(k) and retirement benefits

Job summary

Johnson & Johnson in Danvers, MA, seeks a Production Engineering Manager to oversee technical support for production operations, drive process improvements, and mentor engineers. The role focuses on enhancing manufacturing quality, complying with FDA QSR/ISO standards, and delivering on-time production targets.

You will manage validation activities (IQ/OQ/PQ), lead Kaizen events, and collaborate with Quality to sustain CAPA programs while sustaining productivity and safety across facilities.

Qualifications

• Strong knowledge of FDA QSR, ISO standards, and applicable regulatory requirements.
• 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.

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 Manufacturing

Six Sigma Black Belt

Regulatory compliance

Data-driven decision-making

Problem solving

Project leadership

SAP

Communication

Education

Bachelor's degree in engineering

Master's degree or MBA preferred

Tools

Microsoft Office

SAP

Job description

Johnson & Johnson in Danvers, MA, seeks a Production Engineering Manager to oversee technical support for production operations, drive process improvements, and mentor engineers. The role focuses on enhancing manufacturing quality, complying with FDA QSR/ISO standards, and delivering on-time production targets.

You will manage validation activities (IQ/OQ/PQ), lead Kaizen events, and collaborate with Quality to sustain CAPA programs while sustaining productivity and safety across facilities.