Dexcom
Staff Risk Management Engineer - Quality
About this role
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail.This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes. 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. Where you come in:
- You will be the Quality Lead responsible for the Risk Management File for all on market productsand work with the product core teams to ensure the RMF is up to date
- You will be the Subject Matter Expertfor all on Market Risk Management Files
- You will own and author comprehensive risk analyses and standard risk management documentation, including hazard identification, risk evaluation, risk controls, and residual risk assessments.
- You will perform and manage complex gap assessments, alongside planning, organizing, executing, and reporting on active risk management activities and remediation projects.
- You will effectively support Health Hazard Evaluations (HHE) as a core part of thepost‑marketsurveillance loop
- You will act as the principal advocate for risk management, using yourstrong communicationskills to clearly assess documentation and convey critical risk recommendations to cross-functional stakeholders What makes you successful:
- You willpossessdeepexpertisein ISO 14971:2019 (Risk Management for Medical Devices) and EU MDR (2017/745) risk requirements.
- You willmaintaina strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485.
- You will bring anin‑depthknowledge of industry best practices and emerging trends in risk management processes, tools, and technologies
- You willleveragea strong working knowledge of verification and validation requirements across the medical device industry.