Staff Risk Management Engineer - Quality

Dexcom • Remote California, CA

11d • $111,100 - $185,100 • Remote

About The Position

The Staff Risk Management Engineer serves as the technical leader and subject matter expert for risk management across the medical device lifecycle. This individual ensures compliance with ISO 14971, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and other global regulatory requirements by leading the planning, execution, maintenance, and continuous improvement of product risk management activities. Working cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integrates risk management into product development while ensuring patient safety and regulatory compliance.

Requirements

• Deep expertise in ISO 14971:2019 (Risk Management for Medical Devices) and EU MDR (2017/745) risk requirements.
• Strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485.
• In‑depth knowledge of industry best practices and emerging trends in risk management processes, tools, and technologies.
• Strong working knowledge of verification and validation requirements across the medical device industry.
• Clear understanding of requirements analysis, including the development of testable and measurable specifications.
• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

Nice To Haves

• Preferred knowledge of design controls, post‑market surveillance, and root cause failure analysis.

Responsibilities

• Be the Quality Lead responsible for the Risk Management File for all on market products and work with the product core teams to ensure the RMF is up to date.
• Be the Subject Matter Expert for all on Market Risk Management Files.
• Own and author comprehensive risk analyses and standard risk management documentation, including hazard identification, risk evaluation, risk controls, and residual risk assessments.
• Perform and manage complex gap assessments, alongside planning, organizing, executing, and reporting on active risk management activities and remediation projects.
• Effectively support Health Hazard Evaluations (HHE) as a core part of the post‑market surveillance loop.
• Act as the principal advocate for risk management, using strong communication skills to clearly assess documentation and convey critical risk recommendations to cross-functional stakeholders.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior