Sr Reliability Engineer

Position Overview

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

This position is an onsite role in Fridley, Minnesota, with the benefit of working remotely on Fridays.

• 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 (Design, Human Factors, Medical Safety, Reliability, and Post‑Market Quality) to identify hazards, estimate and evaluate risks, and ensure product/system performance is quantifiably predicted.
• Work with project teams to ensure risk controls are identified and properly implemented, verified, and validated.
• Evaluate the impact of potential issues on patient safety and product performance.
• Perform and document risk assessments and communicate results to leadership and cross‑functional teams.
• Ensure harmonization of risk management strategies across projects and their 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 to achieve required levels of product safety and performance.
• Create documentation in compliance with applicable procedures to meet project deliverables.

• Experience with implantable medical devices.
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (Product Hazard Analysis, Design and Process FMEA, User Analysis).
• Experience with FDA 21 CFR 820, ISO 13485, European Union Medical Device Regulation (MDR), and State of the Art (SOTA).
• Experience with Design Control Deliverables, including Product Performance Specifications, Design Verification, Design Validation, Design Transfer, and Usability and Human Factor Engineering.
• Experience with 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.