Senior Software QA Engineer

This is a fully remote position, open to applicants in California.

📋 Description

• Offer expertise on IEC 62304, 21 CFR Part 820, and global regulatory compliance regarding software development activities.

• Collaborate with firmware, algorithm, and cross-functional teams to produce high-quality embedded medical-device software.

• Act as a core team member representing Software QA throughout the product lifecycle.

• Drive enhancements in software development and validation processes.

• Provide direction on software design, testing, configuration management, tool validation, and system integration.

• Lead and assist in pre-market and post-market risk management, encompassing software anomalies, risk assessments, and CAPA.

• Engage in design reviews, requirements analysis, and cross-functional discussions.

• Contribute to verification and validation efforts throughout the SDLC by utilizing risk-based testing strategies.

• Review and endorse software design-control deliverables, and create DHF artifacts, SOPs, protocols, and reports.

• Evaluate change-control impacts to ensure ongoing product performance and compliance.

• Execute other tasks as assigned.

⛳️ Requirements

• A Bachelor’s degree in a technical field with 5-8 years of relevant experience, or a Master’s degree with 2-5 years of equivalent industry experience, or a PhD with 0-2 years of experience.

• Proficiency in software quality or engineering covering requirements analysis, design/development, product integration, and testing.

• Capability to interpret software design and code to confirm accurate implementation of requirements.

• Practical experience in software development and/or software testing.

• Familiarity with embedded systems and firmware, including hardware/software integration and lab-based testing environments.

• Experience in regulated industries, ideally within medical devices.

• Knowledge of design controls, V&V, and quality systems such as FDA 21 CFR Part 820, IEC 62304, and ISO 13485.

• Understanding of SDLC processes along with Agile and Waterfall methodologies.

• Ability to accommodate San Diego, CA (PST) business hours.

• ASQ Certified Software Quality Engineer (CSQE) certification is preferred.

• Familiarity with continuous glucose monitoring systems or wearable medical devices is a plus.

• Background in signal processing and validation of algorithm-driven systems is advantageous.

• Acquaintance with RTOS and embedded development environments is desirable.

• Experience with CI/CD pipelines for embedded systems is a plus.

• Familiarity with requirements management tools such as Jama is a bonus.

🏝️ Benefits

• A comprehensive benefits program.

• Opportunities for growth on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

• An exciting and innovative organization leading the industry, dedicated to employees, customers, and communities.

• Home office workplace; a hybrid Flex workplace option may be available for employees within commuting distance of a Dexcom site.