Sr Software Design Assurance Engineer

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve health outcomes through innovative technology. The Sr Software Design Assurance Engineer will ensure compliance with regulatory requirements and lead software quality assurance efforts throughout the product lifecycle, focusing on delivering high-quality embedded software for medical devices.

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 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
• 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
• 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