Senior Software QA Engineer

🕒 2 dias atrás

🏄 California – Remoto

🏄 California – Remote

💵 $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

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering on software- and device-related postmarket issues • Drive development and continuous improvement of complaint investigation processes aligned with software risk management activities • Develop and maintain understanding of Dexcom’s software ecosystem and technical architecture • Evaluate product performance, investigate anomalies, and identify continuous-improvement opportunities • Conduct investigations and engineering studies using structured problem-solving, statistical analysis, and industry-standard tools • Analyze, synthesize, and communicate investigation outcomes and recommendations to technical and non-technical stakeholders • Contribute to CAPA, Health Hazard Evaluations, and other quality-system activities • Perform software-focused risk assessments involving product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends • Translate postmarket insights into improvements to product performance, user experience, and patient safety

🎯 Requisitos

• Knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, and EU MDR • 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 • Experience supporting software quality engineering throughout requirements, architecture, design, development, verification, validation, release, and postmarket surveillance • Strong understanding of software risk management principles and methodologies • Ability to communicate complex technical concepts to technical and non-technical stakeholders • Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications • Ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive corrective actions • Experience interpreting data, identifying trends, and translating findings into recommendations • Ability to balance technical depth with business impact, product quality, patient safety, compliance, and customer experience • Willingness to travel 0–5%

🏖️ 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 • Innovative, industry-leading organization committed to employees, customers, and communities • Travel required: 0–5%