Senior Software Design Assurance Engineer - Cloud & AI/ML

Embedded Shishya; California (MO); On-site; USD 95,900 - 159,900; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development through in-house学习

Job summary

Dexcom, a leader in CGM technology, is hiring a Senior Software Design Assurance Engineer to guide regulatory compliance for cloud-based data platforms and AI-enabled systems. You will ensure conformance to IEC 62304, FDA 21 CFR Part 820, ISO 13485, and ISO 14971 while collaborating with cross-functional teams across software, regulatory, and analytics.

You’ll lead risk management deliverables, maintain design history files, and drive continuous improvement of software development and validation

Qualifications

• Bachelor’s degree in a technical discipline and 5–8 years of related experience (or Master’s with 2–5 years).
• Proven knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
• Experience in software design assurance for cloud-based, data platform, API, and service-oriented systems.
• Ability to identify, analyze, and communicate risk and compliance topics to technical teams and leadership.
• Willingness to travel 5–15%.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team for cloud-based, data platform, and AI/ML-driven systems.
• Provide hands-on guidance on regulatory requirements for software-as-a-service and data products.
• Lead software design assurance practices across the SDLC, including requirements traceability and verification.
• Review design control deliverables to ensure regulatory compliance and product quality.
• Support post-market activities related to software issues and CAPA as applicable.
• Prepare and maintain DHFs, SOPs, protocols, and reports for cloud-based/AI systems.

Skills

Software design assurance

SDLC compliance

Cross-functional communication

Requirements traceability

Regulatory awareness

Education

Bachelor’s degree in technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Job description

Dexcom, a leader in CGM technology, is hiring a Senior Software Design Assurance Engineer to guide regulatory compliance for cloud-based data platforms and AI-enabled systems. You will ensure conformance to IEC 62304, FDA 21 CFR Part 820, ISO 13485, and ISO 14971 while collaborating with cross-functional teams across software, regulatory, and analytics.

You’ll lead risk management deliverables, maintain design history files, and drive continuous improvement of software development and validation