Senior Software Design Assurance Engineer – Cloud & AI/ML

Dexcom, Inc.; San Diego (CA); Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development opportunities

Global growth opportunities

Job summary

Dexcom, Inc. is seeking a Senior Software Design Assurance Engineer to support software development processes for cloud-based and AI/ML-enabled systems. You will guide regulatory compliance across IEC 62304, 21 CFR 820, and ISO 13485, helping to ensure safety and quality of data platforms and services.

You will collaborate with Software Engineering, Regulatory Affairs, Marketing, and Cybersecurity to drive risk management, traceability, and continuous improvement in a fast-paced environment.

Qualifications

• Bachelor’s degree in a technical discipline required.
• 5–8 years related experience or advanced degree with relevant experience.
• Experience with software design assurance in cloud-based, data platforms, APIs.
• Knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485.
• Strong cross-functional communication and risk management.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team, supporting SDA for cloud-based data platforms and AI/ML-enabled systems.
• Provide hands-on guidance on IEC 62304, 21 CFR 820, and other global regulations for software-as-a-service and data-driven products.
• Lead effective application and continuous improvement of SDA across the SDLC for distributed systems and cloud services.
• Drive pre-market risk management deliverables, including Software Hazard Analysis (SHA), design FMEA, and risk controls for cloud/data/AI components.
• Review and approve software design control deliverables to ensure traceability and regulatory compliance.
• Support post-market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA as applicable.
• Author, review, and maintain Design History Files, SOPs, protocols, and reports for cloud-based and AI/ML-enabled systems.
• Assess change control activities to ensure no adverse impact on product performance and regulatory compliance.
• Communicate plans, progress, risks, and design assurance considerations to cross-functional teams and senior leadership.

Skills

IEC 62304, FDA 21 CFR Part 820

Software design assurance

Cloud-based software

AI/ML experience

Regulatory compliance

SDLC best practices

Requirements traceability

Education

Bachelor’s degree in a technical discipline

Job description

Dexcom, Inc. is seeking a Senior Software Design Assurance Engineer to support software development processes for cloud-based and AI/ML-enabled systems. You will guide regulatory compliance across IEC 62304, 21 CFR 820, and ISO 13485, helping to ensure safety and quality of data platforms and services.

You will collaborate with Software Engineering, Regulatory Affairs, Marketing, and Cybersecurity to drive risk management, traceability, and continuous improvement in a fast-paced environment.