Senior Software Design Assurance Engineer - Cloud AI

Dexcom Inc.; United States; On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom Inc. is seeking a Senior Software Design Assurance Engineer who provides technical guidance to software teams to ensure conformance to safety and quality standards. The role focuses on cloud-based data platforms, AI/ML-enabled systems, and regulatory compliance across IEC 62304 and 21 CFR 820.

You will lead software design assurance activities, drive risk management deliverables, and collaborate with cross-functional teams to maintain product quality and regulatory readiness.

Qualifications

• Bachelor's degree in a technical discipline with 5–8 years of related experience.
• Hands-on knowledge of IEC 62304, 21 CFR 820, and ISO standards.
• Experience applying quality and regulatory processes to software systems.

Responsibilities

• Provide technical guidance on software design assurance for cloud-based systems.
• Lead software validation practices for distributed data platforms and AI/ML components.
• Manage risk analysis, SHA, and design FMEA related to cloud infrastructure.
• Ensure traceability, configuration management, and tool validation across SDLC.
• Review design controls and regulatory documentation for compliance.
• Support post-market activities including CAPAs and data quality issues.
• Communicate plans and risks to cross-functional teams and leadership.

Skills

Software design assurance

IEC 62304

FDA 21 CFR 820

Regulatory compliance

Education

Bachelor's degree in a technical discipline

Job description

Dexcom Inc. is seeking a Senior Software Design Assurance Engineer who provides technical guidance to software teams to ensure conformance to safety and quality standards. The role focuses on cloud-based data platforms, AI/ML-enabled systems, and regulatory compliance across IEC 62304 and 21 CFR 820.

You will lead software design assurance activities, drive risk management deliverables, and collaborate with cross-functional teams to maintain product quality and regulatory readiness.