Lead Medical Device Risk Management Engineer

Dexcom; California (MO); Remote; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits program

Career development opportunities

Remote work option

Global career growth

Job summary

Dexcom seeks a Staff Risk Management Engineer to lead risk management across the medical device lifecycle. You will own the RMF for on-market products, author comprehensive risk analyses, and drive remediation in cross-functional teams to ensure safety and regulatory compliance.

You will evaluate hazards, implement controls, and support post‑market surveillance and HHE activities, partnering with Regulatory, Quality, and Clinical teams.

Qualifications

• Bachelor’s degree in a technical discipline and 8–12 years of related experience.
• Master’s degree with 5–7 years related experience; PhD with 2–4 years.
• Deep expertise in ISO 14971, EU MDR, and FDA QSR requirements.

Responsibilities

• Lead risk management across the medical device lifecycle.
• Own and maintain the Risk Management File for on-market products.
• Author hazard identifications, risk analyses, and residual risk assessments.
• Support post‑market surveillance and Health Hazard Evaluations (HHE).

Skills

Risk management

ISO 14971

EU MDR

FDA QSR

Verification & Validation

Design controls

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD in technical discipline

Job description

Dexcom seeks a Staff Risk Management Engineer to lead risk management across the medical device lifecycle. You will own the RMF for on-market products, author comprehensive risk analyses, and drive remediation in cross-functional teams to ensure safety and regulatory compliance.

You will evaluate hazards, implement controls, and support post‑market surveillance and HHE activities, partnering with Regulatory, Quality, and Clinical teams.