Staff Software QA Engineer

🕒 4 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $116.600 - $194.400 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Dexcom

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1999

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Dexcom é um dos principais fornecedores de sistemas de monitoramento contínuo de glicose (CGM), revolucionando como as pessoas gerenciam o diabetes e acompanham seus níveis de glicose. Conhecida por sua tecnologia de biossensores de glicose de alta qualidade, a Dexcom oferece produtos como o sistema Dexcom G7 CGM, que fornece monitoramento de glicose em tempo real e insights para ajudar os indivíduos a se tornarem mais saudáveis. Fundada em 1999, a Dexcom tem inovado consistentemente no campo do gerenciamento de diabetes, capacitando os usuários a tomarem controle de sua saúde com soluções precisas e avançadas de monitoramento de glicose. Seus produtos são projetados tanto para adultos quanto para crianças e não exigem receita médica.

Descrição

• 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

🎯 Requisitos

• 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%

🏖️ Benefícios

• 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