Senior Software Design Assurance Engineer – Cloud & AI

1 DexCom Inc; California; Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

CGM technology impact

Global growth opportunities

Tuition reimbursement / career dev

Comprehensive benefits

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to provide technical guidance to software teams ensuring conformance to safety and quality standards across cloud-based and AI-enabled systems. The role interfaces with Software Engineering, Regulatory Affairs, Marketing, and Cybersecurity in a fast-paced environment.

You will lead software design assurance activities, ensure traceability and risk controls, support post-market activities, and contribute to Design History Files, SOPs,

Qualifications

• 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.
• Experience applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification.
• Experience performing software risk management activities, including SHA, design FMEA, and change impact assessments for cloud, data, and AI/ML components.

Skills

AI/ML experience

ASQ CSQE certification

Software design assurance

Regulatory compliance awareness

Education

Bachelor’s degree in a technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to provide technical guidance to software teams ensuring conformance to safety and quality standards across cloud-based and AI-enabled systems. The role interfaces with Software Engineering, Regulatory Affairs, Marketing, and Cybersecurity in a fast-paced environment.

You will lead software design assurance activities, ensure traceability and risk controls, support post-market activities, and contribute to Design History Files, SOPs,