Staff Software Quality Design Engineer

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $116.6k - $194.4k / year

⏰ Full Time

🔴 Lead

🧑‍🔧 Mechanical Engineer

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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

• Provide technical support and guidance to Software teams to ensure conformance with software development processes and applicable safety and quality regulations and standards • Participate as a core member of the R&D Quality Assurance Engineering team supporting software design assurance for cloud-based, data platform, and AI/ML-enabled systems • Provide hands-on guidance on IEC 62304, 21 CFR 820, and global regulations for SaaS, data, and AI-driven products • Lead application, compliance, and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms • Drive pre-market risk management deliverables, including Software Hazard Analysis, design FMEA, and risk controls • Guide Software Design and Test teams on requirements traceability, software configuration management, tool validation, and cloud/data service integration • Review and approve software design control deliverables for cloud-hosted services, data pipelines, and AI/ML components • Support post-market activities involving software anomalies, model behavior, data quality issues, risk assessments, and CAPA • Author, review, and maintain Design History Files, SOPs, protocols, and reports • Assess infrastructure, data, and model change controls for product impact and compliance • Communicate plans, progress, risks, and design assurance considerations to cross-functional teams and senior leadership

🎯 Requirements

• Strong experience in software design assurance for cloud-based, data platform, API, and service-oriented systems in a regulated environment • Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, and ISO 13485 • Experience applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification • Experience performing and reviewing Software Hazard Analysis, design FMEA, and change impact assessments • Skill reviewing and approving software design control deliverables for traceability, risk control implementation, and regulatory compliance • Experience with software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components • Effective communication with cross-functional partners and senior leadership • Bachelor’s degree in a technical discipline and 8–12 years of related experience, or Master’s degree and 5–8 years equivalent industry experience, or PhD and 2–4 years experience • AI/ML experience or ASQ CSQE certification is nice to have • Travel required: 5–15%

🏖️ 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 • An exciting and innovative, industry-leading organization committed to employees, customers, and communities • Home office workplace • Hybrid working environment may be available for employees within commuting distance of a Dexcom site • Flex workplace option