Senior Software V&V Engineer, Imaging Systems

About the role

We are seeking a software verification and validation (V&V) engineer to ensure the quality of cutting-edge products to meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements.

Responsibilities

• 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
• Required Qualifications & Skills
• 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
• Impress us more
• Prior experienc

Benefits

Additional Information

About Cleerly We're Cleerly - a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use. The adherence to all applicable regulatory and statutory requirements establishes a clear framework for setting measurable quality objectives. Our commitment to continually improving our products and processes proactively manages risks, ensuring ongoing compliance throughout the entire software lifecycle. Understanding this role's relevance and importance is critical to achieving Cleerly's quality objectives.

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