Risk Management Engineer — Medical Devices

Actalent; Saint Paul (MN); On-site; USD 96,000 - 117,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k)

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Job summary

Actalent in Saint Paul, MN is seeking a Risk Management Engineer to lead risk management across the product lifecycle for medical devices. You will develop risk management plans, perform hazard analyses, and ensure risk controls are verified.

You will integrate cybersecurity risk considerations and drive improvements within cross-functional teams. The role requires 5–10+ years in risk management, DFMEA/PFMEA/SWFMEA experience, and strong documentation skills.

Qualifications

• Bachelor's degree in engineering or closely related technical discipline.
• 5–10+ years of experience in risk management or related functions within a technical or medical device environment.
• Proven experience in design assurance, with experience supporting product quality and compliance.
• Systems engineering experience, with the ability to understand complex, integrated product architectures.
• Deep expertise in ISO standards relevant to risk management and medical devices.
• Advanced skills in Failure Modes and Effects Analysis (FMEA), including DFMEA, PFMEA, UFMEA, CFMEA, and SWFMEA.
• Demonstrated experience in product lifecycle ownership, managing risk activities from concept through obsolescence.

Responsibilities

• Develop, maintain, and continuously improve risk management plans for products from concept through obsolescence.
• Lead or support hazard analyses and risk assessments to identify, evaluate, and control risks associated with medical devices.
• Facilitate and document DFMEA, PFMEA, UFMEA, CFMEA, and SWFMEA.
• Perform and document formal hazard analyses to support risk management activities.
• Ensure traceability between hazards, risk assessments, risk controls, and verification activities.
• Monitor post-market surveillance data and customer complaints for emerging risks.
• Update risk management files and conduct annual risk reviews.
• Support CAPA activities with risk-based decision-making.
• Own and drive the overall risk strategy across multiple product platforms.
• Integrate cybersecurity risk considerations into patient safety assessments and frameworks.
• Drive process improvements to risk management practices and tools.
• Collaborate with design assurance and systems engineering to embed robust risk management.

Skills

Risk management

FMEA expertise

Systems engineering

Regulatory compliance

Cybersecurity risk integration

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Tools

FMEA software

Risk management tools

Traceability systems

Job description

Actalent in Saint Paul, MN is seeking a Risk Management Engineer to lead risk management across the product lifecycle for medical devices. You will develop risk management plans, perform hazard analyses, and ensure risk controls are verified.

You will integrate cybersecurity risk considerations and drive improvements within cross-functional teams. The role requires 5–10+ years in risk management, DFMEA/PFMEA/SWFMEA experience, and strong documentation skills.