Sr. Reliability Engineer

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 Attribute Test Method Development and Validation. Support pre-market team with complaint prediction and predictive field performance. Utilize statistical analysis tools to analyze data, such as Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Utilize computer and software packages to include MS Office Suite, Prochain, Requs AI Predict, Agile, and Minitab.

Requires a Master's degree in Mechanical, Industrial or Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing, systems or reliability engineer for medical devices. Must possess at least two (2) years' experience with each of the following: 21 CFR Part 820 QSR, ISO 13485, EU MDR, ISO 14971, and IEC 62304; Design Control Deliverables to include Product Performance Specifications, software systems requirements, DVT, Design Phase Reviews, Design Transfer, and Human Factor Engineering; Variable and Attribute Test Methods Development and Validation; Complaint prediction and predictive field performance; ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; and MS Office Suite, Prochain, Requs AI Predict, Agile, and Minitab.

The position will be onsite at least 4 days per week at the Brooklyn Park, MN location., Master's degree in Mechanical, Industrial or Biomedical Engineering or related engineering field

Minimum Experience Required

2 years of experience as a manufacturing, systems or reliability engineer for medical devices