Senior Software Design Assurance Engineer – Cloud & AI/ML

Dexcom; United States; Remote; USD 96,000 - 160,000; Full time

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to provide technical guidance and leadership in software design, validation, and risk management for cloud-based data platforms and AI-enabled services. You will work with cross-functional teams across Software, Regulatory, Marketing, and Cybersecurity to ensure regulatory compliance and product quality.

You will lead activities around SHA, design FMEA, change control, traceability, and validation for SaaS and data-driven solutions,

Qualifications

• Bachelor’s degree in a technical discipline and 5–8 years of related experience.
• Experience in software design assurance for cloud-based, data platform, API, and service-oriented systems in regulated environments.
• Knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485.
• Ability to lead cross-functional reviews across SDLC stages and risk management activities.
• Experience with change control and configuration management.

Responsibilities

• Provide technical guidance on IEC 62304 and 21 CFR 820 compliance.
• Review and approve software design control deliverables.
• Collaborate with Software Engineering, Regulatory Affairs, and Cybersecurity teams.
• Support post-market activities related to software anomalies and CAPA.
• Maintain Design History Files and related documentation.

Skills

Software design assurance

Cloud-based systems

Data platform

API & microservices

Regulatory compliance

Risk management

SDLC

Traceability

Change control

Education

Bachelor’s degree in a technical discipline

Master’s degree

PhD (optional)

Tools

Cloud platforms

Data pipelines

APIs

Tool validation

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to provide technical guidance and leadership in software design, validation, and risk management for cloud-based data platforms and AI-enabled services. You will work with cross-functional teams across Software, Regulatory, Marketing, and Cybersecurity to ensure regulatory compliance and product quality.

You will lead activities around SHA, design FMEA, change control, traceability, and validation for SaaS and data-driven solutions,