Sr. Reliability Engineer

Medtronic • Brooklyn Park, MN

17h • Hybrid

About The Position

Provide reliability engineering support to the new product development lifecycle for medical devices. Develop and support the risk management architecture, and Design for Reliability and Manufacturability (DRM) targets. Support design and phase reviews, and design transfer for software and hardware. Review design and 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.

Requirements

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

Responsibilities

• Provide reliability engineering support to the new product development lifecycle for medical devices.
• Develop and support the risk management architecture, and Design for Reliability and Manufacturability (DRM) targets.
• Support design and phase reviews, and design transfer for software and hardware.
• Review design and 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.

Benefits

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees