1 day ago
Base Salary
$96k - $160k/yr
Responsibilities
- Provide software quality guidance for embedded firmware and algorithm development in compliance with applicable regulatory requirements.
- Lead and improve software development, validation, design-control, configuration-management, tool-validation, and system-integration processes.
- Support pre-market and post-market risk management, including software anomalies, risk assessments, and CAPA activities.
- Participate in design reviews, requirements analysis, verification and validation, and risk-based testing across the SDLC.
- Review and approve software design-control deliverables and author DHF artifacts, SOPs, protocols, and reports.
- Assess change-control impacts and help ensure continued product performance and compliance.
- Represent Software QA as a core team member and collaborate with firmware, algorithm, and cross-functional teams.
Requirements
- Bachelor’s degree in a technical discipline with 5–8 years of related experience, or a master’s degree with 2–5 years of equivalent industry experience, or a PhD with 0–2 years of experience.
- Experience in software quality or engineering covering requirements analysis, design and development, product integration, and testing.
- Hands-on software development and/or software testing experience, including the ability to interpret software design and code against requirements.
- Experience with embedded systems and firmware, hardware/software integration, and laboratory-based testing environments.
- Experience in regulated industries, preferably medical devices, with knowledge of design controls, verification and validation, and quality systems.
- Knowledge of IEC 62304, FDA 21 CFR Part 820, and ISO 13485.
- Ability to communicate technical concepts, work cross-functionally, solve complex problems, and drive projects with minimal supervision.
- Ability to support San Diego, California business hours.
- Preferred: ASQ Certified Software Quality Engineer certification, CGM or wearable medical-device experience, signal processing, algorithm-driven system validation, RTOS and embedded development experience, embedded CI/CD pipeline experience, and Jama experience.
Benefits
- Comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs and qualified tuition reimbursement.
- Remote home-office workplace; employees within approximately 75 miles/120 km of a Dexcom site may have a hybrid option, with a Flex workplace option available.
- Opportunity to work on life-changing continuous glucose monitoring technology in an innovative organization.
About Dexcom
Dexcom designs and manufactures continuous glucose monitoring (CGM) systems for people with diabetes, combining wearable sensors with transmitters, mobile apps, and cloud data services. It sells devices and disposable sensors through pharmacies, durable medical equipment channels, and healthcare providers, often covered by insurance. Founded in 1999 and headquartered in San Diego, Dexcom is a public company traded on NASDAQ (DXCM).