Senior SW Design Quality Engineer

🕒 4 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $95.900 - $159.900 / 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

• Provide technical support and guidance to Software teams to ensure conformance with software development processes and applicable safety and quality regulations and standards • Participate as a core member of the R&D Quality Assurance Engineering team supporting software design assurance for cloud-based, data platform, and AI/ML-enabled systems • Guide cross-functional teams on IEC 62304, 21 CFR 820, and global regulations for SaaS, data, and AI-driven products • Lead application, compliance, and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms • Drive pre-market risk management deliverables, including Software Hazard Analysis, design FMEA, and risk controls • Guide Software Design and Test teams on requirements traceability, software configuration management, tool validation, and cloud/data service integration • Review and approve software design control deliverables for cloud-hosted services, data pipelines, and AI/ML components • Support post-market activities involving software anomalies, model behavior, data quality issues, risk assessments, and CAPA • Author, review, and maintain Design History Files, SOPs, protocols, and reports • Assess infrastructure, data, and model change controls for product impact and compliance • Communicate plans, progress, risks, and design assurance considerations to cross-functional teams and senior leadership

🎯 Requisitos

• Bachelor’s degree in a technical discipline and 5–8 years of related experience, or Master’s degree and 2–5 years equivalent industry experience, or PhD and 0–2 years experience • Strong experience in software design assurance for cloud-based, data platform, API, and service-oriented systems in a regulated environment • Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, and ISO 13485 • Ability to apply software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification • Experience performing and reviewing software risk management activities, including Software Hazard Analysis, design FMEA, and change impact assessments • Skill in reviewing and approving software design control deliverables for traceability, risk control implementation, and regulatory compliance • Experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components • Ability to communicate design assurance, risk, and compliance topics to technical teams and senior leadership • AI/ML experience or ASQ CSQE certification preferred

🏖️ 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 • An exciting and innovative, industry-leading organization committed to employees, customers, and communities • Home office workplace • Hybrid working environment may be available for employees within commuting distance • Flex workplace option • Reasonable accommodations for individuals with disabilities