Sr Software Design Assurance Engineer

Dexcom is a medical device and continuous glucose monitoring technology company. The Senior Software Design Assurance Engineer guides software quality, regulatory compliance, design controls, risk management, and verification and validation for embedded medical-device software, partnering with firmware, algorithm, and cross-functional teams throughout the product lifecycle.

Responsibilities:

• 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

Requirements:

• 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 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
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience
• 0-5%
• 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 background in signal processing and experience validating algorithm-driven systems
• You are familiar with real-time operating systems (RTOS) and embedded development environments
• You have experience with continuous integration and continuous deployment (CI/CD) pipelines for embedded systems
• You have experience using requirements management tools such as Jama