Senior Software Design Assurance Engineer - Cloud & AI

DexCom; California (MO); On-site; USD 140,000 - 190,000; Full time

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to support software design assurance across cloud-based and AI/ML-enabled systems. You will guide teams on IEC 62304, 21 CFR 820, and related regulations, ensuring traceability, validation, and compliance from discovery through post-market.

You will collaborate with Software, Regulatory, Marketing, and Project teams in a fast-paced environment and contribute to risk management and quality improvement initiatives.

Qualifications

• Bachelor’s degree in a technical discipline.
• 5–8 years of related experience in software quality or design assurance.
• Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485.
• Experience applying design assurance across SDLC for cloud/data/AI products.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team.
• Lead software design assurance activities for cloud-based and AI/ML-enabled systems.
• Provide guidance on requirements traceability, configuration management, and validation.
• Review and approve software design control deliverables for regulatory compliance.
• Support post-market activities related to anomalies, risk assessments, and CAPA.
• Communicate plans, risks, and compliance considerations to cross-functional teams.

Skills

Software design assurance

Regulated software development

AI/ML experience

Education

Bachelor’s degree in a technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to support software design assurance across cloud-based and AI/ML-enabled systems. You will guide teams on IEC 62304, 21 CFR 820, and related regulations, ensuring traceability, validation, and compliance from discovery through post-market.

You will collaborate with Software, Regulatory, Marketing, and Project teams in a fast-paced environment and contribute to risk management and quality improvement initiatives.