Senior Software QA Engineer - Medical Device Compliance

Dexcom; United States; On-site; USD 79,000 - 132,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development programs

Tuition reimbursement

Job summary

Dexcom is hiring for a Software Quality Assurance Engineer to join the R&D Quality Assurance Engineering team in the United States. You will guide cross‑functional groups on IEC 62304, 21 CFR 820, ISO 14971 and drive risk management and software validation activities.

The role emphasizes software design, verification, and documentation controls, with collaboration across engineering, regulatory, marketing, and project management to ensure compliant product development.

Qualifications

• Bachelor's degree in a technical discipline and 2–5 years of related experience, or Master’s with 0–2 years equivalent.
• Medical device industry experience and FDA/IEC/ISO knowledge are preferred.
• Experience in software design, development, and verification processes.

Responsibilities

• Participate as a core team member of the R&D Quality Assurance Engineering team.
• Provide guidance on IEC 62304, 21 CFR 820, ISO 14971 to cross‑functional teams.
• Lead application of policies and practices for software development and validation.
• Provide guidance on requirements, risk management deliverables, and traceability.
• Support system validations, design verification, change control, and documentation.
• Communicate plans, status, and challenges to management and teams.

Skills

Mobile apps

SDLC

Agile methodologies

Software quality engineering

Regulatory awareness

Education

Bachelor's degree in a technical discipline

Tools

Jama

Jira

Kettryx

Test Rails

Job description

Dexcom is hiring for a Software Quality Assurance Engineer to join the R&D Quality Assurance Engineering team in the United States. You will guide cross‑functional groups on IEC 62304, 21 CFR 820, ISO 14971 and drive risk management and software validation activities.

The role emphasizes software design, verification, and documentation controls, with collaboration across engineering, regulatory, marketing, and project management to ensure compliant product development.