Sr Software Design Assurance Engineer

Software QA Engineer – Embedded Systems (Medical Devices) At Dexcom, our Software QA Engineering team plays a critical role in delivering life‑changing CGM technology to people worldwide. This role sits at the intersection of firmware and algorithm, working closely with cross‑functional partners to ensure embedded systems meet the highest standards of quality, safety and performance expected in medical devices. Responsibilities Ensure compliance with IEC62304, 21CFR Part820 and other global regulatory requirements across software development activities. Partner closely with firmware, algorithm and cross‑functional teams to deliver high‑quality embedded software for medical devices. Represent Software QA and contribute throughout the product lifecycle, leading and influencing the application, compliance and continuous improvement of software development and validation processes. Provide guidance on software design, testing, configuration management, tool validation and system integration. Lead and support pre‑market and post‑market risk management activities, including software anomalies, risk assessments and CAPA. Actively participate in design reviews, requirements analysis and cross‑functional discussions to drive quality upstream. Contribute to verification and validation activities across the SDLC, focusing on risk‑based testing strategies. Review and approve software design control deliverables and author key technical documentation (e.g., DHF artifacts, SOPs, protocols and reports). Assess change‑control impacts to ensure continued product performance and compliance. Perform additional duties as assigned. Qualifications Experience in software quality or engineering across requirements analysis, design/development, product integration and testing. Ability to interpret software design and code to verify accurate implementation of requirements. Hands‑on experience in software development and/or software testing. Strong communication skills and confidence presenting to all levels of the organization. Experience with embedded systems and firmware, including hardware/software integration and laboratory‑based testing environments. Experience in regulated industries (preferably medical devices) and familiarity with design controls, V&V and quality systems (e.g., FDA 21CFR Part820, IEC62304, ISO13485). Knowledge of SDLC processes and modern development methodologies such as Agile and Waterfall. Effective collaboration with cross‑functional teams and clear communication of complex technical concepts. Driven, hands‑on approach with curiosity to learn new technologies and focus on delivering high‑quality outcomes. Ability to support San Diego, CA (PST) business hours. Nice to have ASQ Certified Software Quality Engineer (CSQE) certification. Experience with continuous glucose monitoring (CGM) systems or wearable medical devices. Background in signal processing and experience validating algorithm‑driven systems. Familiarity with real‑time operating systems (RTOS) and embedded development environments. Experience with continuous integration and continuous deployment (CI/CD) pipelines for embedded systems. Experience using requirements management tools such as Jama. Benefits A front‑row seat to life‑changing CGM technology. Learn about our brave Dexcom warriors 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 employees, customers and the communities we serve. Travel Required: 0–5% Experience and Education Requirements: Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5–8 years related experience or a Master’s degree and 2–5 years equivalent industry experience or a PhD and 0–2 years experience. Salary: $95,900.00 – $159,900.00 Equal Opportunity 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 is an equal‑opportunity employer. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at View email address on click.appcast.io. #J-18808-Ljbffr 1 DexCom Inc