Sr Reliability Engineer Exempt

We are currently seeking a highly skilled professional to join our team in a critical role within the Neuromodulation and Pelvic Health division. This position is based in Fridley, Minnesota, offering the unique advantage of working onsite four days a week with the flexibility of remote work on Fridays.

Responsibilities

• 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 all hazards associated with medical devices are identified, and 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 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.

Qualifications

• 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 including 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.

Join our team and contribute to the advancement of medical device safety and performance in a dynamic and collaborative environment.