Sr. Reliability Engineer

In this critical role as a Senior Risk Management Engineer, you will partner with multidisciplinary project teams to develop and remediate risk management documentation that complies with ISO 14971. This people-focused role requires strong collaboration and communication skills, as well as exceptional attention to detail.
This position will be an onsite role in Fridley, Minnesota with the benefit of working remotely on Fridays.

Responsibilities may include but are not limited to:

• 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 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 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.

Qualifications:

• Bachelor of Science degree with Biomedical Engineering Background
• 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.