Production Engineering Manager, Cardiovascular Operations

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

Job summary

Johnson & Johnson in Danvers, MA, is seeking a Production Engineering Manager to oversee technical support for production operations, drive improvement and validation of manufacturing processes, tooling, and fixtures, and mentor engineers to meet daily schedules while boosting productivity and product quality.

You will lead Lean Six Sigma initiatives, ensure FDA QSR and ISO compliance, manage projects, and develop manufacturing documentation.

Qualifications

• Bachelor’s degree in engineering required; Master’s degree or MBA preferred.
• 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 and develop Production Engineers; manage performance.
• Anticipate and resolve manufacturing challenges through engineering expertise and data-driven decision-making.
• Ensure compliance with FDA QSR, ISO standards, GMP/GDP, and applicable policies and procedures.
• Partner with Quality to drive CAPAs, nonconformance reduction, audit readiness, investigations, and timely corrective actions.
• Qualify, optimize, and monitor manufacturing processes using validation activities (IQ/OQ/PQ), SPC, DOE, Gage R&R, and process capability studies.
• Establish, monitor, and improve KPIs such as safety, quality, yield, productivity, and equipment uptime.
• Lead continuous improvement initiatives using Lean Six Sigma principles, evaluating ROI and timelines.
• Support production operations, process transfers, and global collaboration to meet business objectives.
• Develop, maintain, and improve manufacturing documentation (WIs, procedures, BOMs, PFMEAs).
• Plan and execute engineering projects with schedules, budgets, resources, and deliverables.
• Communicate risks, issues, and opportunities to leadership and stakeholders.

Skills

Lean manufacturing

Six Sigma

Kaizen

Data-driven decision making

Problem-solving

Education

Bachelor's degree in engineering

Master's degree or MBA preferred

Tools

SAP

Job description

Johnson & Johnson in Danvers, MA, is seeking a Production Engineering Manager to oversee technical support for production operations, drive improvement and validation of manufacturing processes, tooling, and fixtures, and mentor engineers to meet daily schedules while boosting productivity and product quality.

You will lead Lean Six Sigma initiatives, ensure FDA QSR and ISO compliance, manage projects, and develop manufacturing documentation.