Manufacturing Engineer

Experienced Manufacturing Engineer responsible for supporting and improving manufacturing processes, production operations, equipment, quality, and productivity. Works cross-functionally with Production, Quality, Engineering, and Supply Chain teams to identify root causes, implement process improvements, support validation activities, reduce costs, and ensure compliance with applicable quality and safety requirements.

• Provide technical leadership and daily manufacturing support for multiple product families within Medtronic's North Haven manufacturing operations.
• Responsible for maintaining and improving product quality, reducing manufacturing costs, optimizing manufacturing processes, and ensuring compliance with safety and regulatory requirements.
• Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate manufacturing issues, perform root cause analysis, qualify components, implement corrective actions, and drive continuous improvement initiatives.
• Support process validation activities, manufacturing process development, equipment improvements, and operational excellence projects.
• Strong problem-solving, manufacturing process knowledge, project management, technical communication, and leadership skills are required.
• Experience with Lean Manufacturing, Six Sigma, CAPA, PFMEA, and medical device quality systems is highly desirable.
• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or a related engineering discipline.
• Provide technical and daily manufacturing support for production operations.
• Develop, optimize, and improve manufacturing processes for quality, cost, efficiency, and productivity.
• Investigate manufacturing issues and perform root cause analysis.
• Implement corrective and preventive actions to resolve process and quality issues.
• Support process validation, equipment qualification, and manufacturing process development.
• Develop and maintain manufacturing documentation, work instructions, and process specifications.
• Analyze production data, process capability, yield, scrap, and cycle-time metrics.
• Drive Lean Manufacturing, Six Sigma, Kaizen, and continuous improvement initiatives.
• Support NPI, process transfer, production ramp-up, and commercialization activities.
• Collaborate with Quality, R&D, Operations, Supplier Quality, and Engineering teams.
• Support equipment selection, installation, troubleshooting, and process optimization.
• Ensure manufacturing processes comply with GMP, ISO, FDA, safety, and company requirements where applicable.
• Participate in PFMEA, Control Plan, risk assessment, and process improvement activities.
• Lead or support engineering projects and track milestones, risks, and deliverables.
• Provide technical guidance and training to manufacturing personnel.
• Identify opportunities to reduce manufacturing costs, waste, downtime, and variability.
• Maintain a strong focus on safety, quality, productivity, and continuous improvement.