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 products and work with the product core teams to ensure the RMF is up to date
- You will be the Subject Matter Expert for 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 the post-market surveillance loop
- You 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 stakeholders
What 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 technologies
- You 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 specification
- You 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 comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required: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.
Salary:
$111,100.00 - $185,100.00
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