Staff Software Quality Assurance Engineer

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $116.6k - $194.4k / year

⏰ Full Time

🔴 Lead

🔧 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

• Serve as a technical leader and subject matter expert for software quality, risk management, and software lifecycle compliance • Lead application, compliance, and continuous improvement of software development and V&V processes, including risk management and software design controls for Class I/II exempt applications and components • Lead complex software quality initiatives spanning multiple products, programs, and functional organizations • Lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues • Support digital transformation initiatives involving ALM, SCM, and PLM systems supporting the SDLC as defined per IEC 62304 • Provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis • Review and approve critical quality deliverables, including software lifecycle documentation, risk artifacts, V&V protocols, and design history file content • Drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes • Evaluate emerging regulations, standards, and industry trends and assess their impact on existing and future products • Collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps • Implement right-sized QMS applications based on software classification per IEC 62304 • Mentor and provide technical leadership to software quality engineers and cross-functional development teams • Influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations • Perform other duties as assigned

🎯 Requirements

• Typically requires a Bachelor’s Degree in a technical discipline and a minimum of 8–12 years related experience, or Master’s degree and 5–7 years equivalent industry experience, or a PhD and 2–4 years of experience • Extensive medical device experience • Demonstrated expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements • Advanced knowledge of software development lifecycle processes and methodologies, including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation • Deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities • Advanced understanding of software risk management principles, methodologies, and regulatory expectations • Ability to influence organizational direction and lead cross-functional initiatives without direct authority • Strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms • Experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors • Exceptional written, verbal, and executive-level communication skills • Ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion • Demonstrated success mentoring engineers and developing organizational quality capabilities

🏖️ 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 • Home office workplace • Flex workplace option may be available for employees within commuting distance of a Dexcom site • 15–25% travel opportunity

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