Remote Senior Software Design QA Engineer - Cloud & AI

Dexcom, Inc.; United States; Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

Travel friendly

Hybrid work arrangement

Comprehensive benefits

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to provide technical guidance to software teams ensuring compliance with IEC 62304, FDA 21 CFR Part 820, and ISO 13485 for cloud-based data and AI/ML-enabled products. You will collaborate across Software, Regulatory Affairs, Quality, and Security to drive risk management, traceability, and validation.

A strong background in software design assurance in regulated environments is essential.

Qualifications

• Typically requires a technical bachelor's degree with 5–8 years of relevant experience.
• Regulatory and quality systems experience in software (IEC 62304, 21 CFR Part 820).
• Nice to have: ASQ CSQE certification and AI/ML experience.

Responsibilities

• Support software design assurance for cloud-based data platform and AI/ML systems.
• Provide cross-functional guidance on IEC 62304, FDA 21 CFR Part 820, ISO 13485.
• Lead or participate in SHA, FMEA, risk controls, and design control deliverables.

Skills

Software design assurance

Cloud-based systems

AI/ML experience

IEC 62304

FDA 21 CFR Part 820

ISO 13485

Education

Bachelor's degree in a technical discipline

Master’s or PhD in a related field

Tools

Tool validation

Software configuration management

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to provide technical guidance to software teams ensuring compliance with IEC 62304, FDA 21 CFR Part 820, and ISO 13485 for cloud-based data and AI/ML-enabled products. You will collaborate across Software, Regulatory Affairs, Quality, and Security to drive risk management, traceability, and validation.

A strong background in software design assurance in regulated environments is essential.