Senior Software V&V Engineer, Imaging Systems

🔥 0 minutes ago

🏄 California, New York, +1 more states – Remote

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

💵 $175k - $206k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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Cleerly

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

🧬 Biotechnology

💰 Series C on 2022-07

Healthcare Insurance • Artificial Intelligence • Biotechnology

Cleerly is a healthcare technology company that specializes in heart disease prevention and treatment through advanced, AI-powered analysis of coronary computed tomography angiography (CCTA) imaging. By providing healthcare professionals with precise and comprehensive insights into heart health, Cleerly aims to reduce the risks associated with traditional cardiac assessments and enable personalized care strategies. Their innovative platform emphasizes non-invasive methods to detect coronary artery disease, improving the accuracy of diagnoses and treatment plans.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

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