Senior Software Design Quality Engineer - Cloud/AI

1 DexCom Inc; California (MO); Hybrid; USD 117,000 - 194,000; Full time

Benefits offered by this job

Full benefits program

Career development programs

Travel opportunities (5–15%)

Job summary

Dexcom is a global leader in continuous glucose monitoring, seeking a Senior Software Design Assurance Engineer to guide software quality across cloud-based and AI/ML powered platforms. You will collaborate with Software Engineering, Regulatory Affairs, Marketing, and Cybersecurity to enforce IEC 62304, 21 CFR 820, and ISO 13485 compliance throughout the SDLC.

Typically requires 8–12 years in regulated environments, with a technical bachelor’s, and remote/hybrid work options.

Qualifications

• Bachelor’s degree in technical discipline required; 8–12 years of related experience or Master’s degree with 5–8 years equivalent experience or PhD with 2–4 years experience.
• Experience in software design assurance for cloud-based, data platform, API, and service-oriented systems in regulated environments.
• Strong knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485 and their application to software-as-a-service and data-driven products.

Responsibilities

• Provide hands-on technical guidance to cross-functional teams on software design assurance.
• Lead software risk management activities including SHA, design FMEA, and change impact assessments.
• Review and approve software design control deliverables to ensure traceability and regulatory compliance.
• Support post-market activities related to software anomalies, risk assessments, and CAPA.

Skills

AI/ML experience

Software design assurance

Cloud-based systems

Regulated environment experience

Requirements traceability

Risk management

Cross-functional communication

Education

Bachelor’s degree in technical discipline

Master’s degree (optional)

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

Job description

Dexcom is a global leader in continuous glucose monitoring, seeking a Senior Software Design Assurance Engineer to guide software quality across cloud-based and AI/ML powered platforms. You will collaborate with Software Engineering, Regulatory Affairs, Marketing, and Cybersecurity to enforce IEC 62304, 21 CFR 820, and ISO 13485 compliance throughout the SDLC.

Typically requires 8–12 years in regulated environments, with a technical bachelor’s, and remote/hybrid work options.