Remote Senior Embedded QA Engineer (Medical Devices)

Dexcom, Inc.; Oregon; Hybrid; USD 96.000 - 160.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Career development

Zusammenfassung

Dexcom, Inc. is seeking a Software QA Engineer to ensure embedded software quality across the SDLC for CGM medical devices. The role requires strong regulatory knowledge and hands-on experience in software quality and testing.

You will collaborate with firmware and algorithm teams to deliver compliant, high-quality embedded software, lead QA activities, and support risk management and validation efforts across the product lifecycle.

Qualifikationen

• Bachelor's degree in a technical discipline with 5–8 years related experience or a higher degree with fewer years
• Experience in software quality or engineering across requirements analysis, design/development, product integration, and testing
• Familiarity with IEC 62304, 21 CFR Part 820, ISO 13485 and design controls in regulated medical devices

Aufgaben

• Ensure compliance with IEC 62304 and 21 CFR Part 820 across software development activities and provide guidance to ensure compliance
• Collaborate with firmware, algorithm, and cross-functional teams to deliver high-quality embedded software for medical devices
• Lead Software QA efforts, review design controls deliverables, and support risk management activities including CAPA and software anomalies
• Participate in design reviews, requirements analysis, and V&V activities to drive quality upstream

Kenntnisse

SoftwareQA engineering

Embedded systems

Regulated industries knowledge

SDLC processes

Agile/Waterfall

Ausbildung

Bachelor's degree in a technical discipline

Jobbeschreibung

Dexcom, Inc. is seeking a Software QA Engineer to ensure embedded software quality across the SDLC for CGM medical devices. The role requires strong regulatory knowledge and hands-on experience in software quality and testing.

You will collaborate with firmware and algorithm teams to deliver compliant, high-quality embedded software, lead QA activities, and support risk management and validation efforts across the product lifecycle.