Senior Software QA Engineer

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $95.9k - $159.9k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering on software- and device-related postmarket issues • Drive development and continuous improvement of complaint investigation processes aligned with software risk management activities • Develop and maintain understanding of Dexcom’s software ecosystem and technical architecture • Evaluate product performance, investigate anomalies, and identify continuous-improvement opportunities • Conduct investigations and engineering studies using structured problem-solving, statistical analysis, and industry-standard tools • Analyze, synthesize, and communicate investigation outcomes and recommendations to technical and non-technical stakeholders • Contribute to CAPA, Health Hazard Evaluations, and other quality-system activities • Perform software-focused risk assessments involving product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends • Translate postmarket insights into improvements to product performance, user experience, and patient safety

🎯 Requirements

• Knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, and EU MDR • Bachelor’s degree in a technical discipline and 5–8 years of related experience, or Master’s degree and 2–5 years equivalent industry experience, or PhD and 0–2 years experience • Experience supporting software quality engineering throughout requirements, architecture, design, development, verification, validation, release, and postmarket surveillance • Strong understanding of software risk management principles and methodologies • Ability to communicate complex technical concepts to technical and non-technical stakeholders • Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications • Ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive corrective actions • Experience interpreting data, identifying trends, and translating findings into recommendations • Ability to balance technical depth with business impact, product quality, patient safety, compliance, and customer experience • Willingness to travel 0–5%

🏖️ Benefits

• A full and comprehensive benefits program • Growth opportunities on a global scale • Access to career development through in-house learning programs and/or qualified tuition reimbursement • Innovative, industry-leading organization committed to employees, customers, and communities • Travel required: 0–5%