Remote Senior Software Quality Engineer - Embedded Medical

Regulatory Jobs; United States; Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development

Tuition reimbursement

Job summary

Dexcom is seeking a Software QA Engineer to join the regulatory and quality team in San Diego, CA. You will ensure software for CGM devices meets IEC 62304, FDA 21 CFR Part 820, and international standards, partnering with firmware, algorithm, and cross-functional teams.

You will lead verification and validation activities, reviews of design controls, risk management, and CAPA, while guiding software development processes and tool validation.

Qualifications

• Experience in software quality or engineering across requirements analysis, design, development, and testing.
• Ability to interpret software design and code to verify implementation of requirements.
• Hands-on experience in software development and/or software testing.
• Familiar with design controls, V&V, and quality systems in regulated industries.
• Experience with embedded systems and firmware testing environments.

Responsibilities

• Guide compliance across software development activities per IEC 62304 and FDA regulations.
• Lead software design, testing, configuration management, tool validation, and integration.
• Support pre-market and post-market risk management, including CAPA.
• Review design controls deliverables and key DHF artifacts.
• Participate in design reviews and risk assessments to improve quality.

Skills

Software quality engineering

Embedded systems

Regulatory compliance

Software requirements analysis

Testing and verification

Cross-functional collaboration

Education

Bachelor's degree in technical discipline

Master's or PhD (optional)

Tools

Jama

Job description

Dexcom is seeking a Software QA Engineer to join the regulatory and quality team in San Diego, CA. You will ensure software for CGM devices meets IEC 62304, FDA 21 CFR Part 820, and international standards, partnering with firmware, algorithm, and cross-functional teams.

You will lead verification and validation activities, reviews of design controls, risk management, and CAPA, while guiding software development processes and tool validation.