Senior Medical Device Risk Management Engineer

Embedded Shishya; United States; Remote; USD 111,000 - 185,000; Full time

Benefits offered by this job

Life changing CGM technology

Comprehensive benefits program

In-house learning & tuition assistance

Global growth opportunities

Job summary

Dexcom seeks a Staff Risk Management Engineer to lead risk management across the medical device lifecycle, ensuring ISO 14971, EU MDR, and FDA QSR compliance.

You will collaborate with Systems, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post‑Market Surveillance to own risk analyses, drive RMF updates, and support post‑market activities. Travel 5–15% is required, remote work options may apply.

Qualifications

• Bachelor's degree in a technical discipline with 8–12 years of related experience or a Master’s degree and 5–7 years of experience or PhD with 2–4 years of experience.
• Expertise in ISO 14971 and regulatory requirements.
• Strong knowledge of FDA QSR, EU MDR and ISO 13485.
• Experience leading risk management activities across the medical device lifecycle.
• Experience with post-market surveillance and Health Hazard Evaluations (HHE) is a plus.

Responsibilities

• Own and lead Risk Management File for on‑market products and keep RMF up to date.
• Serve as Subject Matter Expert for all on‑market Risk Management files.
• Author comprehensive risk analyses, hazard identification, risk evaluations, controls, and residual risk assessments.
• Manage gap assessments and plan/execute remediation activities.
• Support Health Hazard Evaluations as part of post‑market surveillance loop.
• Communicate risk findings clearly to cross‑functional stakeholders.

Skills

ISO 14971

EU MDR

FDA QSR (21 CFR 820/860)

Regulatory compliance

Risk management

Verification & validation

Education

Bachelor's degree in technical discipline

Master's degree in technical field

PhD with related experience

Tools

Risk assessment methodologies

Design controls

Job description

Dexcom seeks a Staff Risk Management Engineer to lead risk management across the medical device lifecycle, ensuring ISO 14971, EU MDR, and FDA QSR compliance.

You will collaborate with Systems, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post‑Market Surveillance to own risk analyses, drive RMF updates, and support post‑market activities. Travel 5–15% is required, remote work options may apply.