Senior Software Design Assurance Engineer – Cloud & AI

United States Digital Space LLC; United States; Remote; USD 117,000 - 194,000; Full time

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to join our R&D Quality Assurance team. The role focuses on ensuring conformance to software development processes and global regulatory standards for cloud-based and AI-enabled systems.

You will guide cross-functional teams on IEC 62304, FDA 21 CFR Part 820, ISO 13485, and related practices within a fast-paced environment. Remote-friendly position with travel 5-15%; requires a technical bachelor’s degree and 8+ years of relevant

Qualifications

• Bachelor’s degree in a technical discipline with 8+ years of related experience.
• Experience applying IEC 62304, FDA 21 CFR Part 820, ISO 13485 to software products.
• Strong background in cloud-based, data-driven software systems in regulated environments.

Responsibilities

• Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
• Provide hands-on guidance to teams on IEC 62304, 21 CFR 820, and other regulations.
• Lead software development and validation practices for distributed cloud services and data platforms.
• Drive pre-market risk management deliverables, including SHA, design FMEA, and risk controls.
• Guide design and test teams on traceability, configuration management, tool validation, and data services.
• Review and approve software design control deliverables to ensure compliance and quality.
• Support post-market activities related to software anomalies, risk assessments, and CAPA.
• Author, review, and maintain DHFs, SOPs, protocols, and reports for cloud/AI systems.
• Assess change control activities to ensure no adverse impact on product performance.
• Communicate plans, progress, risks, and design assurance considerations to leadership.

Skills

Software design assurance

Cloud-based systems

IEC 62304

FDA 21 CFR Part 820

ISO 13485

SDLC

Risk management

Software Hazard Analysis

FMEA

Change control

Documentation

Cross-functional communication

Education

Bachelor’s degree in a technical discipline

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to join our R&D Quality Assurance team. The role focuses on ensuring conformance to software development processes and global regulatory standards for cloud-based and AI-enabled systems.

You will guide cross-functional teams on IEC 62304, FDA 21 CFR Part 820, ISO 13485, and related practices within a fast-paced environment. Remote-friendly position with travel 5-15%; requires a technical bachelor’s degree and 8+ years of relevant