Senior Medical Device Risk Management Engineer (ISO 14971)

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

Benefits offered by this job

Benefits program

Global growth opportunities

Tuition reimbursement

Career development programs

Job summary

Dexcom Inc. is seeking a Staff Risk Management Engineer to lead risk management across the medical device lifecycle. You will own and update the Risk Management File for all on‑market products and collaborate with product teams to ensure RMF completeness.

You will apply ISO 14971:2019, EU MDR, and FDA QSR/ISO 13485 knowledge to perform hazard analyses, risk evaluations, and residual risk assessments, while driving remediation and supporting post‑market surveillance initiatives.

Qualifications

• Deep expertise in ISO 14971:2019 and EU MDR risk requirements.
• Strong understanding of FDA Quality System Regulations and ISO 13485.
• Experience in risk analyses, hazard identification, and remediation planning.

Responsibilities

• Lead Risk Management File for on‑market products and keep RMF up to date.
• Author comprehensive risk analyses, hazard identifications, and residual risk assessments.
• Plan and manage gap assessments and remediation projects.
• Support Health Hazard Evaluations as part of post‑market surveillance.
• Communicate risk findings clearly to cross‑functional stakeholders.

Skills

Risk management expertise

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in technical discipline

Tools

ISO 14971:2019

EU MDR 2017/745

FDA QSR (21 CFR 820/860)

ISO 13485

Risk management tools

Job description

Dexcom Inc. is seeking a Staff Risk Management Engineer to lead risk management across the medical device lifecycle. You will own and update the Risk Management File for all on‑market products and collaborate with product teams to ensure RMF completeness.

You will apply ISO 14971:2019, EU MDR, and FDA QSR/ISO 13485 knowledge to perform hazard analyses, risk evaluations, and residual risk assessments, while driving remediation and supporting post‑market surveillance initiatives.