Senior Software V&V Engineer, Imaging Systems

🕒 Junho 4

🏄 California, New York, +1 estados a mais – Remoto

🏄 California – Remote 🗽 New York – Remote 🤠 Texas – Remote

💵 $175.000 - $206.000 / ano

⏰ Tempo Integral

🟠 Sênior

👷🏻‍♀️ Engenheiro

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Cleerly

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2017

⚕️ Seguro de Saúde

🤖 Inteligência Artificial

🧬 Biotecnologia

💰 Series C em 2022-07

Healthcare Insurance • Artificial Intelligence • Biotechnology

A Cleerly é uma empresa de tecnologia na área de saúde que se especializa na prevenção e tratamento de doenças cardíacas através de análises avançadas e impulsionadas por IA de imagens de angiotomografia coronariana por tomografia computadorizada (CCTA). Ao fornecer aos profissionais de saúde insights precisos e abrangentes sobre a saúde do coração, a Cleerly visa reduzir os riscos associados às avaliações cardíacas tradicionais e possibilitar estratégias de cuidado personalizadas. Sua plataforma inovadora enfatiza métodos não invasivos para detectar doenças das artérias coronárias, melhorando a precisão dos diagnósticos e planos de tratamento.

Descrição

• Develop and lead the Design Verification and Validation (V&V) plan in compliance with regulatory and quality system requirements (21 CFR Part 820, ISO 13485, ISO 14971). • Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance. • Build complex data sets to be used in test • Statistical Analysis and Exploratory Data Analysis (e.g., descriptive statistics, regression, visualization) • Developed test methods and verification protocols for software product • Create and maintain test master plans, schedules, and resource allocation for multiple device programs. • Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables. • Collaborate with cross-functional teams to understand requirements and translate them into comprehensive test plans and protocols • Data Governance, Access Controls, and PHI Data Handling

🎯 Requisitos

• 5+ years equivalent work experience in medical imaging industry(Product Development, Quality) • Bachelor’s or Master's degree in Computer Science, Information Technology, or related field. • Experience with non-product software development • Strong programming skills in Python across data science, statistical analysis, big data and ML stack • Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR • Expertise in issue tracking and project management tools like JIRA • Strong understanding of the software development life cycle and testing life cycle. • Excellent problem-solving, analytical, and critical thinking skills • Ability to work collaboratively in a remote-first team environment and to communicate effectively with Product Managers, Engineers, and other stakeholders.

🏖️ Benefícios

• 15% target annual bonus • Stock options • Paid benefits