Senior Software Design Assurance Engineer – Cloud & AI

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

Benefits offered by this job

Comprehensive benefits package

Growth opportunities

Career development programs

Travel 5-15%

Job summary

Dexcom, Inc. is seeking a Sr Software Design Assurance Engineer to guide software teams in conformance with IEC 62304, ISO 13485, and FDA/regulatory standards for SaaS, data platforms, and AI-driven products.

You will lead SHA, design FMEA, and ensure traceability across SDLC while supporting post-market activities and cross-functional collaboration with R&D, Regulatory, and Cybersecurity teams.

Qualifications

• Experience with IEC 62304, FDA 21 CFR Part 820, ISO 13485 and their application to software-as-a-service and data-driven products.
• Strong experience in risk management activities including SHA and design FMEA.

Responsibilities

• Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
• Interface with cross-functional teams across Software Engineering, Regulatory, Quality, and Leadership.
• Lead Software Hazard Analysis (SHA), design FMEA, and risk controls for cloud, data, and AI components.
• Review and approve software design control deliverables for traceability and regulatory compliance.
• Support post-market activities related to software anomalies and CAPA as applicable.
• Develop and maintain Design History Files, SOPs, and related regulatory documentation.

Skills

AI/ML experience

Regulatory compliance knowledge

Software design assurance

Cloud-based / SaaS experience

Communication to leadership

Education

Bachelor’s degree in technical discipline

Master’s degree in technical field

PhD in technical field

Job description

Dexcom, Inc. is seeking a Sr Software Design Assurance Engineer to guide software teams in conformance with IEC 62304, ISO 13485, and FDA/regulatory standards for SaaS, data platforms, and AI-driven products.

You will lead SHA, design FMEA, and ensure traceability across SDLC while supporting post-market activities and cross-functional collaboration with R&D, Regulatory, and Cybersecurity teams.