Sr. Reliability Engineer

Job description

Position Description: Sr. Reliability Engineer for Medtronic, Inc located in Brooklyn Park, MN. Provide reliability engineering support the new product development lifecycle for medical devices. Develop and support the risk mgmt. architecture, Design for Reliability and Manufacturability (DRM) targets. Support design and phase reviews, design transfer for software and hardware. Review design, change specifications, and plan against contractual and process requirements. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Utilize selective Software Reliability Prediction Model for the Cardiac Surgery Business to improve reliability. Navigate the complexity of government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union Medical Device Regulation (EU MDR), ISO 14971, and IEC 62304. Support design control deliverables to include Product Performance Specifications, Design Verification & Design Validation Testing (DVT), Design Phase Reviews, Design Transfer, and Human Factor Engineering. Provide support for Variable and Att...