Senior Software Design Quality Engineer for Cloud & AI

Dexcom; United States; Remote; USD 117,000 - 194,000; Full time

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to guide software quality across cloud-based data platforms and AI/ML-enabled systems. You will ensure compliance with IEC 62304, 21 CFR 820, and ISO 13485, and lead risk management and design control activities across the SDLC.

The role interfaces with software, regulatory, and security teams to drive quality, risk reduction, and post-market vigilance in a fast-paced CGM environment.

Qualifications

• Experience with software design assurance in regulated environments.
• Knowledge of IEC 62304, 21 CFR 820, ISO 13485.
• Ability to lead risk management activities for cloud data and AI/ML components.

Responsibilities

• Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
• Guide design and test teams on SDLC, traceability, and regulatory requirements.
• Review and approve software design control deliverables for cloud-hosted services and data pipelines.
• Support post-market activities including software anomalies, risk assessments, and CAPA.
• Author, review, and maintain Design History Files, SOPs, protocols, and reports.

Skills

Software design assurance

Cloud-based systems

Regulatory compliance

AI/ML experience

ISO 13485

IEC 62304

FDA 21 CFR Part 820

SDLC oversight

Education

Bachelor's degree in technical discipline

Master's degree

Tools

Cloud platforms

Data pipelines

Software configuration management

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to guide software quality across cloud-based data platforms and AI/ML-enabled systems. You will ensure compliance with IEC 62304, 21 CFR 820, and ISO 13485, and lead risk management and design control activities across the SDLC.

The role interfaces with software, regulatory, and security teams to drive quality, risk reduction, and post-market vigilance in a fast-paced CGM environment.