Sr. Reliability Engineer

Medtronic • Lafayette, CO

19h • Hybrid

About The Position

Support engineering function within new product development for large development lifecycle of complex electro-mechanical & electronic medical devices. Design test methods and statistical process control procedures for achieving required levels of product reliability. Compiles and analyzes performance reports and process control statistics & investigates and analyzes relevant variables potentially affecting product and processes. Responsible for Medical Device Risk and deliverables to include Risk Analysis, Design, Use and Process Failure Mode Effects Analysis (xFMEAs), and Risk Assessment. Author reliability studies and evaluations of engineering design concepts and DOE constructs. Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry regulations to include FDA 21 CFR part 820, ISO 9001, ISO 13485, and ISO 14971. Coordinate Complaint and Product Failure Investigations, pre and post market root cause analysis, and CAPA. Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation and Design Transfer, and Usability and Human Factor Engineering. Develop design or test methods, mathematical models utilizing statistical tools and Reliasoft software. Leverage Predict product life by utilizing Reliability models based on Physics of Failure (PoF) Run analytical assessment from fatigue perspective. Utilize nCode and NASTRAN for the assessment. Design accelerated life testing (ALT) and highly accelerated life testing (HALT) to rapidly induce and identify failure mechanisms and extrapolate results to real-world conditions. Integrate Physics of Failure insights into reliability block diagrams (RBDs), fault tree analysis (FTA), and other reliability prediction techniques. Relocation assistance is not available for this position. Position works a hybrid model and will be onsite in Lafayette, CO – 4 days per week. #LI-DNI

Requirements

• Master’s degree in Mechanical, Electrical or Biomedical Engineering and two (2) years of experience as a Reliability or Quality Engineer or related occupation in reliability or quality engineering; or Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering and five (5) years of experience as a Reliability or Quality Engineer or related occupation in reliability or quality engineering.
• Must possess at least two (2) years of experience with each of the following:
• Reliability studies and evaluations of engineering design concepts and DOE constructs
• Complaint and Product Failure Investigations, pre and post market root cause analysis, and CAPA
• Product Performance Specifications, Design Verification, Design Validation and Design Transfer, and Usability and Human Factor Engineering
• Developing design or test methods, mathematical models utilizing statistical tools and Reliasoft software
• Predicting product life by utilizing Reliability models based on Physics of Failure (PoF) and analytical assessment from fatigue perspective
• nCode and NASTRAN for the assessment
• Design accelerated life testing (ALT) and highly accelerated life testing (HALT)
• Integrate Physics of Failure insights into reliability block diagrams (RBDs) and fault tree analysis (FTA)

Responsibilities

• Support engineering function within new product development
• Design test methods and statistical process control procedures
• Compile and analyze performance reports and process control statistics
• Investigate and analyze relevant variables affecting product and processes
• Responsible for Medical Device Risk and deliverables
• Author reliability studies and evaluations of engineering design concepts and DOE constructs
• Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366
• Navigate the complexities of various government and industry regulations to include FDA 21 CFR part 820, ISO 9001, ISO 13485, and ISO 14971
• Coordinate Complaint and Product Failure Investigations, pre and post market root cause analysis, and CAPA
• Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation and Design Transfer, and Usability and Human Factor Engineering
• Develop design or test methods, mathematical models utilizing statistical tools and Reliasoft software
• Leverage Predict product life by utilizing Reliability models based on Physics of Failure (PoF)
• Run analytical assessment from fatigue perspective
• Utilize nCode and NASTRAN for the assessment
• Design accelerated life testing (ALT) and highly accelerated life testing (HALT)
• Integrate Physics of Failure insights into reliability block diagrams (RBDs), fault tree analysis (FTA), and other reliability prediction techniques

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: Mid Level
• Number of Employees: 5,001-10,000 employees