Software Design Assurance Engineer II

Dexcom Inc.; San Diego, Northern (CA, KY); Hybrid; USD 79,000 - 132,000; Full time

Job summary

Dexcom Inc. is seeking a Software Design Assurance Engineer to support software teams and ensure conformance to medical device software standards (IEC 62304, FDA 21 CFR Part 820).

The role focuses on product improvement, new development, and defect prevention across cross-functional groups. You will guide design controls, risk management, and continuous improvement, while interacting with Regulatory Affairs, Cybersecurity, Marketing, and Project Management teams to ensure compliant software

Qualifications

• Typically requires a Bachelor’s degree in a technical discipline and 2–5 years of related experience, or a Master’s degree and 0–2 years of equivalent industry experience.
• Experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485 for medical devices.
• Ability to interpret software design and code to verify implementation of requirements.

Responsibilities

• Act as a core team member of the R&D Quality Assurance Engineering team.
• Provide guidance on regulatory requirements (IEC 62304, 21 CFR 820) across software teams.
• Review, author, and revise software design control deliverables.
• Support post-market activities related to software anomalies and CAPA.

Skills

Cross-functional collaboration

Regulatory knowledge

Communication

Quality mindset

Education

Bachelor’s degree in a technical discipline

Master’s degree (advantage)

Job description

Dexcom Inc. is seeking a Software Design Assurance Engineer to support software teams and ensure conformance to medical device software standards (IEC 62304, FDA 21 CFR Part 820).

The role focuses on product improvement, new development, and defect prevention across cross-functional groups. You will guide design controls, risk management, and continuous improvement, while interacting with Regulatory Affairs, Cybersecurity, Marketing, and Project Management teams to ensure compliant software