Senior Risk Engineer

We are seeking a Sr. Risk Management Engineer for a very important client. This role will support risk management sustaining activities within the medical device space, with a focus on Class III medical devices, ISO 14971, and maintaining strong risk management documentation. This is an onsite role in Fridley, Minnesota, with the benefit of working remotely on Fridays.

About the Role

In this critical position, you will work closely with cross-functional project teams to create, update, and remediate risk management documents in compliance with ISO 14971 and applicable medical device quality standards. This role requires strong attention to detail, excellent communication skills, and the ability to drive alignment across technical and quality teams.

Responsibilities

• Maintain and update Risk Management Files for Class III medical devices.
• Apply ISO 14971 risk management practices, including Hazard Analysis, Product Hazard Analysis, Design FMEA, Process FMEA, and User Analysis.
• Collaborate with Design, Human Factors, Medical Safety, Reliability, Post-Market Quality, and other cross-functional teams.
• Ensure risk controls are properly identified, implemented, verified, and validated.
• Perform and document risk assessments and communicate results to leadership and project teams.
• Support design control deliverables, including Product Performance Specifications, Design Verification, Design Validation, Design Transfer, and Usability / Human Factors Engineering.
• Evaluate potential issues related to patient safety and product performance.
• Identify opportunities for continuous improvement within the risk management process.

Qualifications

• Bachelor’s degree in Biomedical Engineering or related technical field.
• 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.
• Experience working with Quality Design Control deliverables.
• Experience with FDA 21 CFR 820, ISO 13485, EU MDR, and State of the Art requirements.
• Experience with implantable medical devices.
• Strong knowledge of risk analysis techniques such as FMEA, hazard analysis, risk assessment, and user analysis.
• Experience applying statistics in a medical device or quality engineering environment.
• Strong attention to detail with the ability to maintain accuracy and thoroughness.
• Demonstrated leadership skills with the ability to facilitate discussions and drive consensus on complex topics.

Nice to Have

• Experience with data analytics.
• Experience supporting vertebral augmentation or related medical device products.
• Self-motivated learner who actively seeks new knowledge, skills, and solutions.

Ideal Candidate

The ideal candidate is proactive, detail-oriented, and comfortable working with cross-functional teams to ensure risk controls and documentation meet regulatory and quality expectations. This person should be able to guide discussions, drive alignment, and support risk management activities throughout the product lifecycle.