Remote Senior Software Design Quality Engineer - Cloud/AI

Dexcom Inc.; Northern (KY); Hybrid; USD 96,000 - 160,000; Full time

Job summary

Dexcom Inc. is seeking a Senior Software Design Quality Engineer to provide hands-on guidance in software design assurance for cloud-based, data platform, and AI/ML-enabled systems.

The role interfaces with cross-functional teams to ensure IEC 62304, FDA 21 CFR Part 820, and ISO 13485 compliance across the SDLC. You will drive risk management deliverables, including SHA and design FMEA, and oversee change control for cloud infrastructure and data pipelines.

Qualifications

• Bachelor’s degree in a technical discipline; 5–8 years related experience, or Master’s with 2–5 years, or PhD with 0–2 years.
• Experience with IEC 62304, FDA 21 CFR Part 820, ISO 13485 in software-as-a-service and data-driven products.
• Knowledge of software design assurance across SDLC: requirements analysis, design reviews, implementation oversight, verification.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team for cloud-based and AI/ML-enabled systems.
• Provide guidance on IEC 62304, 21 CFR 820, and global regulations to cross-functional teams.
• Lead software design assurance activities: requirements traceability, configuration management, tool validation, cloud/data services integration.
• Review and approve software design control deliverables to ensure regulatory compliance and product quality.

Skills

Software design assurance

Cloud-based systems

Regulatory compliance

SDLC

Risk management

Education

Bachelor’s degree in technical discipline

Job description

Dexcom Inc. is seeking a Senior Software Design Quality Engineer to provide hands-on guidance in software design assurance for cloud-based, data platform, and AI/ML-enabled systems.

The role interfaces with cross-functional teams to ensure IEC 62304, FDA 21 CFR Part 820, and ISO 13485 compliance across the SDLC. You will drive risk management deliverables, including SHA and design FMEA, and oversee change control for cloud infrastructure and data pipelines.