Senior Software QA Engineer

🔥 2 minutes ago

🏄 California – Remote

infoinfo

💵 $95.9k - $159.9k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Logo of Dexcom

Dexcom

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

• Provide guidance on IEC 62304, 21 CFR Part 820, and global regulatory compliance across software development activities • Partner with firmware, algorithm, and cross-functional teams to deliver high-quality embedded medical-device software • Represent Software QA as a core team member throughout the product lifecycle • Lead and improve software development and validation processes • Provide guidance on software design, testing, configuration management, tool validation, and system integration • Lead and support pre-market and post-market risk management, including software anomalies, risk assessments, and CAPA • Participate in design reviews, requirements analysis, and cross-functional discussions • Contribute to verification and validation activities across the SDLC using risk-based testing strategies • Review and approve software design-control deliverables and author DHF artifacts, SOPs, protocols, and reports • Assess change-control impacts for continued product performance and compliance • Perform other duties as assigned

🎯 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 • Experience in software quality or engineering across requirements analysis, design/development, product integration, and testing • Ability to interpret software design and code to verify accurate implementation of requirements • Hands-on experience in software development and/or software testing • Experience with embedded systems and firmware, including hardware/software integration and lab-based testing environments • Experience in regulated industries, preferably medical devices • Familiarity with design controls, V&V, and quality systems including FDA 21 CFR Part 820, IEC 62304, and ISO 13485 • Knowledge of SDLC processes and Agile and Waterfall methodologies • Ability to support San Diego, CA (PST) business hours • ASQ Certified Software Quality Engineer (CSQE) certification (nice to have) • Experience with continuous glucose monitoring systems or wearable medical devices (nice to have) • Background in signal processing and algorithm-driven systems validation (nice to have) • Familiarity with RTOS and embedded development environments (nice to have) • Experience with CI/CD pipelines for embedded systems (nice to have) • Experience using requirements management tools such as Jama (nice to have)

🏖️ 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 • An exciting and innovative, industry-leading organization committed to employees, customers, and communities • Home office workplace; hybrid Flex workplace option may be available for employees within commuting distance of a Dexcom site

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