Principal Software Quality Assurance Engineer

🕒 Junho 2

❄️ Minnesota, Texas – Remoto

❄️ Minnesota – Remote 🤠 Texas – Remote

💵 $124.000 - $170.500 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Solventum

SiteLinkedInTodas as Vagas

10.000+ funcionários

⚕️ Seguro de Saúde

📚 Educação

🧘 Bem-estar

Healthcare Insurance • Education • Wellness

Solventum é uma empresa focada em saúde, conhecida por suas soluções inovadoras voltadas para melhorar os resultados dos cuidados médicos e odontológicos. A empresa oferece uma variedade de tecnologias médicas, incluindo cuidados avançados para feridas, soluções cirúrgicas e produtos de esterilização. A Solventum também fornece soluções avançadas para cuidados orais, serviços de tecnologia e informação em saúde, e produtos de purificação e filtração para aplicações biofarmacêuticas. Além disso, a Solventum dá forte ênfase à sustentabilidade e educação, oferecendo recursos e treinamento para profissionais de saúde em todo o mundo. Seu compromisso com a inovação e com a melhoria da saúde fez dela uma líder na indústria de saúde, dedicada a aprimorar a segurança dos pacientes e a eficiência dos cuidados médicos.

Descrição

• Leading software assurance activities throughout medical device software life cycle • Creating software quality assurance plan • Determining software safety classification • Software test readiness and software release readiness • Ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing • Being an active member of the software team during the whole software life cycle • Responsibility for physical and functional configuration audits • Reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results • Providing insight to management regarding software project status and software quality metrics • Ensuring compliance with applicable regulatory requirements and industry standards • Performing gap assessments • Immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements • Acting as a quality champion in software product development and testing teams • Supporting other software related processes such as CAPA process and other quality related processes regarding cybersecurity risk management and software quality assurance.

🎯 Requisitos

• Master’s degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science and five (5) years of experience in software quality assurance in medical device, aerospace, or automotive industry OR Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security or Information Science and seven (7) years of experience in software quality assurance in medical device, aerospace, or automotive industry • Working knowledge of premarket and postmarket medical device regulations (FDA, EU and other agencies) • Experience developing and testing software systems, SaMD, SiMD, and/or embedded software and creating appropriate documentation • Knowledge of Software Engineering best practices and working knowledge of C language preferred • Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies • Excellent verbal and written communication skills • Strong problem-solving ability and attention to detail • Ability to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teams • Ability to deal effectively with other employees and external business contacts while conveying a positive, service-oriented attitude.

🏖️ Benefícios

• Medical, Dental & Vision • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits