Senior Software Design Assurance Engineer – Cloud & AI

Dexcom Inc.; Northern (KY); Hybrid; USD 117,000 - 194,000; Full time

Benefits offered by this job

Benefits program

Growth opportunities

Tuition reimbursement

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to guide software quality for cloud-based data platforms and AI/ML systems. You will drive regulatory compliance (IEC 62304, FDA 21 CFR 820) and ensure robust quality across SDLC components.

You will lead risk assessments (SHA, FMEA) and collaborate with cross-functional teams while supporting post-market activities and documentation. This role offers remote/hybrid work with travel and strong growth opportunities.

Qualifications

• Bachelor’s degree in a technical discipline; 8–12 years of related experience or advanced degree equivalents.
• Hands-on knowledge of IEC 62304 and FDA 21 CFR Part 820.
• Experience applying SDLC, requirements traceability, risk management in regulated contexts.
• Strong communication with cross-functional teams and leadership in design assurance.

Responsibilities

• Support software design assurance for cloud-based data platforms and AI/ML systems.
• Provide hands-on guidance on IEC 62304, 21 CFR 820, and global regulations for SaaS/data products.
• Lead risk management deliverables: SHA, design FMEA, risk controls for cloud/data/AI components.
• Review and approve software design control deliverables to ensure traceability and regulatory compliance.

Skills

Software design assurance

Cloud-based systems

AI/ML experience

Regulated environment

Education

Bachelor’s degree in technical discipline

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to guide software quality for cloud-based data platforms and AI/ML systems. You will drive regulatory compliance (IEC 62304, FDA 21 CFR 820) and ensure robust quality across SDLC components.

You will lead risk assessments (SHA, FMEA) and collaborate with cross-functional teams while supporting post-market activities and documentation. This role offers remote/hybrid work with travel and strong growth opportunities.