Production Engineering Manager – MedTech Cardio

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

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