Sr Software Design Assurance Engineer

Requirements

• You hold an ASQ Certified Software Quality Engineer (CSQE) certification.
• You have experience with continuous glucose monitoring (CGM) systems or wearable medical devices.
• You bring a backgro

Benefits

Additional Information

The Company Dexcom 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: *This is not a test role* At Dexcom, our Software QA Engineering team plays a critical role in delivering life-changing continuous glucose monitoring (CGM) technology to people around the world. This role sits at the intersection of firmware and algorithm, working closely with cross-functional partners to ensure our embedded systems meet the highest standards of quality, safety, and performance expected in medical devices. You'll join a driven and highly collaborative team that values curiosity, ownership, and design excellence. We are deeply engaged with firmware and algorithm development teams, contributing early and often throughout the product lifecycle. If you enjoy solving complex problems, learning new technologies, and making a real impact on patient outcomes, this is the place for you. Where you come in: You bring a strong understanding of IEC 62304, 21 CFR Part 820, and other global regulatory requirements, and provide guidance to ensure compliance across software development activities. You partner closely with firmware, algorithm, and cross-functional teams to deliver high-quality embedded software for medical devices. You serve as a core team member representing Software QA, contributing throughout the product lifecycle. You lead and influence the effective application, compliance, and continuous improvement of software development and validation processes. You provide guidance on software design, testing, configuration management, tool validation, and system integration. You lead and support pre-market and post-market risk management activities, including software anomalies, risk assessments, and CAPA. You actively participate in design reviews, requirements analysis, and cross-functional discussions to drive quality upstream. You contribute to verification and validation activities across the SDLC, with a strong focus on risk-based testing strategies. You review and approve software design control deliverables and author key technical documentation (e.g., DHF artifacts, SOPs, protocols, and reports). You assess change control impacts to ensure continued product performance and compliance. You will assume and perform other duties as assigned. What makes you successful: You bring experience in software quality or engineering across requirements analysis, design/development, product integration, and testing. You can interpret software design and code to verify accurate implementation of requirements. You have hands-on experience in software development and/or software testing. You communicate effectively and confidently present to all levels of the organization. You are able to navigate complex problems, break them down, and drive projects to completion with minimal supervision. You have experience working with embedded systems and firmware, including hardware/software integration and lab-based testing environments. You have experience in regulated industries (preferably medical devices) and are familiar with design controls, V&V, and quality systems (e.g., FDA 21 CFR Part 820, IEC 62304, ISO 13485). You are knowledgeable in SDLC processes and modern development methodologies such as Agile and Waterfall. You collaborate effectively with cross-functional teams and clearly communicate complex technical concepts. You bring a driven, hands-on approach, with a curiosity to learn new technologies and a focus on delivering high-quality outcomes. You must be able to support San Diego, CA (PST) business hours

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