Sr Software QA Engineer
About The Position
Dexcom is seeking a Senior Software QA Engineer to help ensure the quality, safety, performance, and regulatory compliance of embedded software for continuous glucose monitoring medical devices. The role works at the intersection of firmware and algorithms and partners closely with development and cross-functional teams throughout the product lifecycle. The engineer leads and supports software quality activities, including design controls, verification and validation, risk management, change control, and continuous improvement of software development processes. The position includes reviewing and approving software design control deliverables, authoring technical documentation, and providing guidance on software design, testing, configuration management, tool validation, and system integration. The role supports San Diego, California (PST) business hours. The position is remote, with a home office; employees within commuting distance of a Dexcom site may have a hybrid option. The position typically requires a bachelor's degree in a technical discipline and 5–8 years of related experience, a master's degree and 2–5 years of equivalent industry experience, or a PhD and 0–2 years of experience.
Requirements
- Typically, a bachelor's degree in a technical discipline and 5–8 years of related experience, a master's degree and 2–5 years of equivalent industry experience, or a PhD and 0–2 years of experience.
- Experience in software quality or engineering across requirements analysis, design and 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.
- Effective communication skills and confidence presenting to all levels of the organization.
- Ability to navigate complex problems, break them down, and drive projects to completion with minimal supervision.
- Experience with embedded systems and firmware, including hardware/software integration and lab-based testing environments.
- Experience in regulated industries, preferably medical devices, and familiarity with design controls, verification and validation, and quality systems such as FDA 21 CFR Part 820, IEC 62304, and ISO 13485.
- Knowledge of SDLC processes and modern development methodologies such as Agile and Waterfall.
- Ability to collaborate effectively with cross-functional teams and clearly communicate complex technical concepts.
- A driven, hands-on approach, curiosity to learn new technologies, and focus on delivering high-quality outcomes.
- Ability to support San Diego, California (PST) business hours.
Nice To Haves
- 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.
Responsibilities
- Provide guidance on IEC 62304, 21 CFR Part 820, and other global regulatory requirements to support compliance across software development activities.
- Partner with firmware, algorithm, and cross-functional teams to deliver high-quality embedded software for medical devices.
- Represent Software QA as a core team member throughout the product lifecycle.
- Lead and influence 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.
- Participate in design reviews, requirements analysis, and cross-functional discussions to drive quality upstream.
- Contribute to verification and validation activities across the SDLC, with a focus on risk-based testing strategies.
- Review and approve software design control deliverables and author technical documentation, including DHF artifacts, SOPs, protocols, and reports.
- Assess change control impacts to ensure continued product performance and compliance.
- Perform other duties as assigned.
Benefits
- Full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Career development through in-house learning programs and/or qualified tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
