Senior Embedded QA Engineer (Medical Devices)

1 DexCom Inc; California; Híbrido; USD 96.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flex workplace option

Comprehensive benefits program

Career growth opportunities

Descripción de la vacante

Dexcom seeks an experienced Software QA Engineer to ensure high-quality embedded software for CGM devices. You will apply IEC 62304, 21 CFR Part 820, and risk management across the SDLC, collaborating with firmware, algorithm, and cross-functional teams to deliver compliant software.

You will lead design reviews, guide software design, testing, and configuration management, and support pre/post-market activities.

Formación

• Experience in software quality or engineering across requirements analysis, design/development, product integration, and testing.
• Interpret software design and code to verify accurate implementation of requirements.
• Hands-on experience in software development and/or software testing.
• Familiar with design controls, V&V, and quality systems (e.g., FDA 21 CFR Part 820, IEC 62304, ISO 13485).
• Experience with embedded systems and firmware, including hardware/software integration and lab-based testing environments.

Responsabilidades

• Lead and influence the effective 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.
• Review and approve software design control deliverables and author key technical documentation (e.g., DHF artifacts, SOPs, protocols, and reports).
• Assess change control impacts to ensure continued product performance and compliance.

Conocimientos

Embedded systems experience

Firmware

Regulatory knowledge

Software quality

Design controls

V&V

SDLC

Agile/Waterfall

Cross‑functional collaboration

Strong communication

Educación

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD (optional)

Herramientas

Jama

Descripción del empleo

Dexcom seeks an experienced Software QA Engineer to ensure high-quality embedded software for CGM devices. You will apply IEC 62304, 21 CFR Part 820, and risk management across the SDLC, collaborating with firmware, algorithm, and cross-functional teams to deliver compliant software.

You will lead design reviews, guide software design, testing, and configuration management, and support pre/post-market activities.