Sr Reliability Engineer; Sr Risk Engineer

We are currently looking for a Sr Risk Engineer to work within the Neuromodulation and Pelvic Health to drive and support risk management sustaining activities.

Location:

onsite role in Fridley, Minnesota with the benefit of working remotely on Fridays.

Schedule:

4 days a week onsite and 1 day remote; targeted starting date:
May 4, 2026. Start interview ASAP.

• Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices.
• Collaborate with cross-functional teams (Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to identify hazards, estimate and evaluate associated risks, and predict product/system performance.
• Work with project teams to ensure risk controls are identified and properly implemented, verified, and validated.
• Evaluate impact of potential issues on patient safety and product performance.
• Perform and document Risk Reviews to communicate results of the risk management process.
• Ensure harmonization of risk management strategies across projects and lifecycle by communicating with other Risk Management team members.
• 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.

• At least 5 years of experience within Medical Device.
• At least 3 years of experience with ISO 14971 in a medical device company.
• At least 3 years of experience creating or maintaining risk management files for medical devices.
• At least 3 years of experience working with Quality Design Control deliverables.
• 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 MDR, and State of the Art.
• Experience with Design Control Deliverables including Product Performance Specifications, Design Verification, Validation, Transfer, Usability and Human Factor Engineering.
• Experience in the application of statistics.
• Strong attention to detail.
• 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.

• Spinal Cord Stimulation, Deep Brain Stimulation, Pelvic Health.