Cleerly, founded in 2016, is a digital healthcare company specializing in AI-powered diagnostic solutions to transform cardiovascular care. Leveraging coronary computed tomography
Senior Software V&V Engineer, Imaging Systems
Location
California + 2 moreAll locations: California | New York | Texas
Posted
9 days ago
Salary
$175K - $206K / year
Seniority
Senior
Job Description
Senior Software V&V Engineer, Imaging Systems
Cleerly
• 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
Job 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
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