Sr Reliability Engineer

Medtronic seeks a Senior Quality Engineer for new product development in surgical devices. The role focuses on supplier management, manufacturing process qualification, and design transfer, ensuring medical devices meet quality and regulatory standards.

Responsibilities

• Evaluate and qualify suppliers; manage Approved Supplier List and supplier performance reviews
• Oversee Production Part Approval Process, process validation (IQ/OQ/PQ), and Master Validation Planning
• Manage Non-Conformance Material Reports and supplier corrective actions across production lifecycle
• Lead cross-functional design transfer activities and collaborate on design controls, FMEA, and manufacturability
• Conduct statistical analysis of manufacturing performance and occasional supplier site visits domestically and internationally

Requirements

• Bachelor's degree in engineering or related technical field with 4+ years relevant experience, or advanced degree with 2+ years
• Extensive knowledge of manufacturing processes for plastics, metals, electronics, and product assembly
• Deep expertise in GD&T, FMEA, and design for manufacturability principles
• Extensive experience in regulated medical device environments
• Strong analytical and root cause analysis capabilities
• Proven leadership and project management skills managing multiple concurrent initiatives
• Proficiency in quality management systems, risk management, and statistical analysis