Senior Software Design Assurance Engineer - Cloud & AI

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

Benefits offered by this job

Comprehensive benefits

Career development

Job summary

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

You will ensure conformance to software development processes and regulatory standards across cross-functional teams. The role emphasizes risk management, requirements traceability, and post-market support, with a focus on cloud services, data pipelines, and platform components.

Qualifications

• Typically requires a Bachelor's degree in a technical discipline and 5–8 years related experience or a Master's degree with 2–5 years equivalent industry experience or a PhD with 0–2 years experience.
• Experience with software design assurance for cloud-based, data platform, API, and service-oriented systems in regulated environment.
• Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485 and their application to software-as-a-service and data-driven products.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team, supporting software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
• Provide hands-on technical guidance on IEC 62304, 21 CFR 820 and other global regulations for SaaS, data, and AI-driven products.
• Lead the application, compliance, and improvement of software development and validation practices for distributed systems, cloud services, and data platforms.
• Drive pre-market risk management deliverables, including Software Hazard Analysis (SHA), design FMEA, and risk controls for cloud infra and AI/ML components.
• Guide Software Design and Test teams on requirements traceability, configuration management, tool validation, and cloud/data service integration.
• Review and approve software design control deliverables for traceability and regulatory compliance.
• Support post-market activities related to software anomalies, data quality issues, CAPA, and risk assessments.
• Author, review, and maintain DHFs, 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 compliance.
• Communicate plans, progress, risks, and design assurance considerations to cross-functional teams and senior leadership.

Skills

Software design assurance

Cloud-based systems

AI/ML systems

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

Job description

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

You will ensure conformance to software development processes and regulatory standards across cross-functional teams. The role emphasizes risk management, requirements traceability, and post-market support, with a focus on cloud services, data pipelines, and platform components.