Remote Lead Medical Device Software QA Engineer

Dexcom, Inc; San Diego (CA); Hybrid; USD 117,000 - 194,000; Full time

Benefits offered by this job

Flex workplace option

Job summary

Dexcom Corporation is seeking a senior software quality leader to own risk management and lifecycle compliance across multiple medical device projects. You will mentor engineers, review critical quality artifacts, and drive improvements in V&V, DFMEA/PFMEA, and regulatory readiness.

Collaboration with R&D, regulatory, and leadership will shape quality strategy and implementation. Experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971 is essential, as is strong communication and

Qualifications

• Bachelor's, Master's or PhD in a technical field.
• Strong software quality & risk management experience preferred.
• Regulatory knowledge across FDA/IEC standards is essential.

Responsibilities

• Lead complex software quality initiatives across multiple products and teams.
• Mentor software quality engineers and cross-functional staff.
• Review critical quality deliverables including SDLC documents, risk artifacts, V&V protocols.

Education

Bachelor's Degree in a technical discipline

Master's Degree in a technical discipline

PhD in a technical discipline

Job description

Dexcom Corporation is seeking a senior software quality leader to own risk management and lifecycle compliance across multiple medical device projects. You will mentor engineers, review critical quality artifacts, and drive improvements in V&V, DFMEA/PFMEA, and regulatory readiness.

Collaboration with R&D, regulatory, and leadership will shape quality strategy and implementation. Experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971 is essential, as is strong communication and