Sr Reliability Engineer - Exempt

Careers That Change Lives

Location:

This position is based in Minneapolis, MN, offering the vibrant city life and a thriving medical technology hub. Enjoy the benefit of working remotely on Fridays while being part of a dynamic team.

In this critical role, you will work closely with multidisciplinary project teams to maintain and remediate risk management documents that meet ISO 14971. This role is people-oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail.

• Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.
• Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.
• Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Evaluate impact of potential issues to patient safety and product performance.
• Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle.
• Identify and act upon opportunities for continuous improvement of the Risk Management Process.
• Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance.
• Create documentation in compliance with applicable procedures to meet project deliverables.

Must-Have:
Minimum Requirements

• Experience with implantable medical devices.
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).
• Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).
• Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.
• Experience in the application of statistics.
• Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.
• Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.
• Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.