Senior Embedded Quality Engineer – Medical Devices

Dexcom, Inc.; Sacramento (CA); Remote; USD 96.000 - 160.000; Vollzeit

Benefits dieser Stelle

Full benefits

Career development

Global growth opportunities

Zusammenfassung

Dexcom, Inc. is seeking a Software QA Engineer to join the embedded software and algorithm teams. You will ensure the highest standards of quality, safety and performance for medical devices across the product lifecycle.

You will work with firmware, algorithm and cross-functional teams to implement robust validation, risk management, and design control practices. This role requires hands-on testing, strong communication, and the ability to operate within a regulated environment in San Diego, CA

Qualifikationen

• Experience in software quality engineering across requirements analysis, design, development and testing.
• Experience with embedded systems and firmware.
• Knowledge of regulatory standards (FDA 21 CFR Part 820, IEC 62304) and V&V processes.
• Strong written and verbal communication across levels.

Aufgaben

• Lead software quality assurance activities for embedded medical devices.
• Ensure compliance with regulatory requirements across the SDLC.
• Participate in design reviews, requirements analysis and cross-functional discussions.
• Drive software validation, risk assessment and CAPA activities.
• Review and approve software design control deliverables and SOPs.

Jobbeschreibung

Dexcom, Inc. is seeking a Software QA Engineer to join the embedded software and algorithm teams. You will ensure the highest standards of quality, safety and performance for medical devices across the product lifecycle.

You will work with firmware, algorithm and cross-functional teams to implement robust validation, risk management, and design control practices. This role requires hands-on testing, strong communication, and the ability to operate within a regulated environment in San Diego, CA