Staff Risk Management Engineer – Quality

🔥 14 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $111.1k - $185.1k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• Serve as technical leader and subject matter expert for risk management across the medical device lifecycle • Ensure compliance with ISO 14971, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and other global regulatory requirements • Lead planning, execution, maintenance, and continuous improvement of product risk management activities • Act as Quality Lead responsible for Risk Management Files for all on-market products • Work with product core teams to keep Risk Management Files up to date • Own and author risk analyses and risk management documentation, including hazard identification, risk evaluation, risk controls, and residual risk assessments • Perform and manage complex gap assessments • Plan, organize, execute, and report on risk management activities and remediation projects • Support Health Hazard Evaluations as part of the post-market surveillance loop • Advocate for risk management and communicate critical risk recommendations to cross-functional stakeholders • Collaborate with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance

🎯 Requirements

• Bachelor’s degree in a technical discipline and 8–12 years of related experience, or Master’s degree and 5–7 years of equivalent industry experience, or PhD and 2–4 years of experience • Deep expertise in ISO 14971:2019 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 • Understanding of requirements analysis, including development of testable and measurable specifications • Preferred knowledge of design controls, post-market surveillance, and root cause failure analysis • Travel required: 5–15%

🏖️ Benefits

• Full and comprehensive benefits program • Growth opportunities on a global scale • Career development through in-house learning programs and/or qualified tuition reimbursement • Innovative, industry-leading organization committed to employees, customers, and communities