Staff Risk Management Engineer - Quality

Dexcom; California (MO); Remote; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits program

Career development opportunities

Remote work option

Global career growth

Job summary

Dexcom seeks a Staff Risk Management Engineer to lead risk management across the medical device lifecycle. You will own the RMF for on-market products, author comprehensive risk analyses, and drive remediation in cross-functional teams to ensure safety and regulatory compliance.

You will evaluate hazards, implement controls, and support post‑market surveillance and HHE activities, partnering with Regulatory, Quality, and Clinical teams.

Qualifications

• Bachelor’s degree in a technical discipline and 8–12 years of related experience.
• Master’s degree with 5–7 years related experience; PhD with 2–4 years.
• Deep expertise in ISO 14971, EU MDR, and FDA QSR requirements.

Responsibilities

• Lead risk management across the medical device lifecycle.
• Own and maintain the Risk Management File for on-market products.
• Author hazard identifications, risk analyses, and residual risk assessments.
• Support post‑market surveillance and Health Hazard Evaluations (HHE).

Skills

Risk management

ISO 14971

EU MDR

FDA QSR

Verification & Validation

Design controls

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD in technical discipline

Job description

The CompanyDexcom 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 r esponsible for the Risk Management File for all on market products and work with the product core teams to ensure the RMF is up to dateYou will be the Subject Matter Expert for all on Market Risk Management FilesYou 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 the post ‑ market surveillance loopYou will act as the principal advocate for risk management, using your strong communication skills to clearly assess documentation and convey critical risk recommendations to cross-functional stakeholdersWhat makes you successful :You will possess deep expertise in ISO 14971:2019 (Risk Management for Medical Devices) and EU MDR (2017/745) risk requirements.You will maintain a strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485.You will bring an in ‑ depth knowledge of industry best practices and emerging trends in risk management processes, tools, and technologiesYou will leverage a strong working knowledge of verification and validation requirements across the medical device industry.You will demonstrate a clear understanding of requirements analysis, including the development of testable and measurable specificationYou will ideally possess preferred knowledge of design controls, post ‑ market surveillance, and root cause failure analysis.What you’ll get :A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .A full and c omprehensive benefit s progra m .Growth opportunities on a global scale.Access to career development through in-house learning programs and/or qualified tuition reimbursemen t.An exciting and innovative , industry - leading organization committed to our employees , customers , and the communities we serve .Travel Required:5-15%Experience and Education Requirements: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.Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail] you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail], an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=trueTo all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.Salary:$111,100.00 - $185,100.00#DexcomUS