Senior Software Design Assurance for AI & Cloud

1 DexCom Inc; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to support software design assurance for cloud-based, data platform, and AI/ML-enabled systems. You will provide guidance to cross-functional teams on IEC 62304 and global regulatory requirements, focusing on SaaS and data-driven products.

The role emphasizes risk management, design control, and post-market support. The ideal candidate has hands-on experience with SDLC, software risk management, and the ability to communicate complex

Qualifications

• Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485 and applying them to software-as-a-service and data-driven products.
• Experience in software design assurance across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification.
• Experience performing and reviewing software risk management activities, SHA, design FMEA, and change impact assessments for cloud, data, and AI components.
• Ability to clearly present design assurance, risk, and compliance topics to technical teams and senior leadership.

Responsibilities

• Provide hands-on technical guidance to cross-functional teams on IEC 62304, 21 CFR 820, and other applicable global regulations for software-as-a-service, data, and AI-driven products.
• Lead the application and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms.
• Drive pre-market risk management deliverables, including Software Hazard Analysis (SHA), design FMEA, and risk controls for cloud infrastructure, data processing, and AI/ML functionality.
• Review and approve software design control deliverables to ensure traceability, risk control implementation, and regulatory compliance.
• Support post-market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA.

Skills

Software design assurance

Regulatory compliance

SDLC expertise

Risk management

Cloud-based systems

AI/ML exposure

Education

Bachelor's degree in a technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

Software validation tools

Tool validation

Job description

Dexcom is seeking a Senior Software Design Assurance Engineer to support software design assurance for cloud-based, data platform, and AI/ML-enabled systems. You will provide guidance to cross-functional teams on IEC 62304 and global regulatory requirements, focusing on SaaS and data-driven products.

The role emphasizes risk management, design control, and post-market support. The ideal candidate has hands-on experience with SDLC, software risk management, and the ability to communicate complex