Staff Software QA Engineer

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $116.6k - $194.4k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 activities • Lead the application, compliance, and continuous improvement of software development and V&V processes, including risk management and software design controls • 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 under IEC 62304 • Provide technical oversight and direction for DFMEA, PFMEA, SHA, and hazard analysis • Review and approve software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content • Drive improvements in software quality systems, development practices, automation, verification, validation, and compliance processes • Evaluate emerging regulations, standards, and industry trends and assess their impact on products • Collaborate with senior leadership to define quality strategies and implement right-sized QMS applications based on IEC 62304 software classification • Mentor software quality engineers and cross-functional development teams • Influence project, product, and organizational decisions through risk-based quality assessments and recommendations • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in a technical discipline and 8–12 years of related experience, or Master’s degree and 5–7 years of equivalent industry experience, or 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 Agile, Waterfall, DevOps, CI/CD, and test automation methodologies • Deep software quality engineering experience 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 interacting with the 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 completion • Demonstrated success mentoring engineers and developing organizational quality capabilities • Willingness to travel 15–25%

🏖️ 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 • Front row seat to life changing CGM technology • An exciting and innovative, industry-leading organization committed to employees, customers, and communities