Senior Staff Software QA Engineer

🕒 Julho 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $135.100 - $225.100 / ano

⏰ Tempo Integral

🟠 Sênior

🔧 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

• Provides technical leadership for software quality assurance activities, including risk management activities following ISO 14971, with a focus on Product Model and Clinical Apps. • Supports the development and implementation of scalable quality systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance. • Partners with senior R&D engineering, Quality, Regulatory, Clinical, Cybersecurity, and business leaders to drive continuous improvements to SDLC, and quality excellence throughout the product lifecycle. • Influences organizational quality strategy and serves as a recognized subject matter expert in supporting Clinical product portfolio, risk management, and regulatory compliance. • Develop and drive enterprise-level software quality strategies, policies, procedures, and best practices across the Clinical Applications and Hospital space. • Serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities. • Lead the effective application, compliance, and continuous improvement of software development and V&V processes, including: Risk Management, Product model, and Clinical support, 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. • Lead digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined per IEC62304. • 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 development 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 impact to existing and future products. • Collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps, implementing a right-sized QMS for Non-Clinical applications. • 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.

🎯 Requisitos

• 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. • Expert knowledge of software development lifecycle processes and software development 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. • Demonstrated 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.

🏖️ Benefícios

• A front row seat to life changing CGM technology. • Learn about our brave #dexcomwarriors community. • 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 our employees, customers, and the communities we serve.