Remote Staff Risk Management Engineer - Medical Devices

Dexcom Inc.; California (MO); Hybrid; USD 111,000 - 185,000; Full time

Benefits offered by this job

Benefits program

Growth opportunities

Job summary

Dexcom Corporation is seeking a Staff Risk Management Engineer - Quality in a remote/California‑based role. The engineer will lead risk management across the medical device lifecycle, author RMFs, and ensure regulatory compliance with ISO 14971, FDA QSR 21 CFR 820, and EU MDR.

Collaboration with Systems, Design, Regulatory, and Quality teams is essential. Key tasks include hazard identification, risk evaluation, control implementation, and supporting health hazard evaluations to strengthen

Qualifications

• Typically requires a Bachelor’s degree in a technical discipline and 8–12 years of related experience, or a Master’s degree with 5–7 years of experience, or a PhD with 2–4 years of experience.

Responsibilities

• Lead risk management activities across the medical device lifecycle.
• Own and author comprehensive risk analyses and RMF for on‑market products.
• Ensure compliance with ISO 14971, 21 CFR 820, EU MDR; support post‑market surveillance and hazard evaluations.
• Collaborate with cross‑functional teams to integrate risk management into product development.

Skills

Risk management

Regulatory knowledge

ISO 14971

EU MDR

FDA QSR 21 CFR 820

Hazard analysis

Documentation

Education

Bachelor's degree in a technical discipline

Master's degree in a related field

PhD (optional)

Tools

Regulatory databases

Risk management software

Job description

Dexcom Corporation is seeking a Staff Risk Management Engineer - Quality in a remote/California‑based role. The engineer will lead risk management across the medical device lifecycle, author RMFs, and ensure regulatory compliance with ISO 14971, FDA QSR 21 CFR 820, and EU MDR.

Collaboration with Systems, Design, Regulatory, and Quality teams is essential. Key tasks include hazard identification, risk evaluation, control implementation, and supporting health hazard evaluations to strengthen