Senior Software QA Engineer

🔥 44 minutes ago

🇺🇸 United States – Remote

💵 $95.9k - $159.9k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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, data-driven approaches, 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 product performance, user experience, and patient safety improvements

🎯 Requirements

• Bachelor’s degree in a technical discipline and 5–8 years related experience, or Master’s degree and 2–5 years equivalent industry experience, or PhD and 0–2 years experience • Knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and other applicable global regulations • Experience supporting software quality engineering activities throughout the product lifecycle • Strong understanding of software risk management principles and methodologies • Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications • Experience applying engineering fundamentals and structured problem-solving techniques • Experience interpreting data, identifying trends, and translating findings into actionable recommendations • Excellent communication and collaboration skills • Ability to balance technical depth with business impact

🏖️ Benefits

• A full and comprehensive benefits program • Growth opportunities on a global scale • Career development through in-house learning programs and/or qualified tuition reimbursement • 0–5% travel required