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Strong fit if you own software quality systems in regulated devices and want CGM impact at scale. Thin public employee-sentiment data; quality-control news is a live context for the role.
As a Senior Software Design Assurance / Design Quality Engineer at Dexcom, expect risk files, software V&V evidence, design-control reviews, CAPA/complaint inputs, and cross-functional work with SW, quality, and regulatory on CGM software under FDA design controls—not product feature coding.
No—design assurance focuses on process, risk, and evidence that software meets quality and regulatory expectations.
Sensor recalls and supply authenticity issues raise the bar for design controls and software/data integrity rigor.
Listing is California-oriented with remote indicated; Dexcom R&D is in San Diego.
Website: dexcom.com
Dexcom, Inc. is an American multinational healthcare company that develops, manufactures, produces and distributes a line of continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with global headquarters and R&D center in San Diego, California, U.S., and manufacturing facilities in Mesa, Arizona, U.S.; Batu Kawan, Malaysia; and Athenry, County Galway, Ireland.
Public cache only — not an employee review.
Senior Software Design Assurance (Sr Software Design Quality) Engineer at DexCom, California - Full Time Remote The Opportunity DexCom Corporation, a pioneer and global leader in continuous glucose monitoring (CGM), seeks a Senior Software Design Assurance Engineer to join our team. As a key member of the software development process, you will provide technical support and guidance to ensure conformance to safety and quality system regulations such as IEC 62304, ISO 13485, and ISO 14971. Key Responsibilities Provide technical support and guidance to software teams for product improvement and new production initiatives Evaluate and ensure compliance with applicable safety and quality system regulations and standards Contribute to the development of software design assurance processes and methodologies Participate in risk management activities, including hazard analysis and mitigation planning Collaborate with cross-functional teams to ensure alignment with regulatory requirements Requirements Bachelor's degree in Computer Science, Electrical Engineering, or a related field; Master’s degree preferred Minimum of 5 years of experience in software design assurance or quality engineering for medical devices Familiarity with IEC 62304, ISO 13485, and ISO 14971 standards Experience with risk management processes and tools Strong communication and collaboration skills Ability to work in a fast-paced environment and handle multiple priorities More About DexCom Dexcom Corporation, founded 25 years ago, has been at the forefront of continuous glucose monitoring technology. Our mission is to empower people to take control of their health through personalized, actionable insights. We are committed to reinventing unique biosensing-technology experiences and continuously improving human health on a global scale. Join our team of ambitious, passionate individuals who are dedicated to earning the trust of our customers by listening, serving with integrity, thinking big, and being dependable. Together, we are shaping the future of consumer health technology while addressing important health challenges. How to Apply To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.
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