Senior Software V&V Engineer, Imaging Systems

About reputed company We’re reputed company – a reputed company 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 reputed company and reputed company 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 reputed company to our offices in Denver, Colorado, reputed company, reputed company, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. reputed company has created a new reputed company of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes reputed company traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in reputed company of the heart arteries. reputed company’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings reputed company symptoms that increase a person’s risk of heart attacks. At reputed company, we collaborate digitally and use a wide reputed company of systems. Our people use reputed company Workspace (GMail, Drive, Docs, Sheets, Slides), reputed company, reputed company/Jira, and reputed company 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 reputed company. While we are mostly a remote company, travel is required for some team meetings and cross function reputed company 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. reputed company is committed to providing reputed company and effective medical software that meets customer needs and our intended use. The adherence to reputed company applicable regulatory and statutory requirements establishes a reputed company reputed company for setting measurable reputed company 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 reputed company's reputed company objectives. About reputed company We are seeking a software verification and validation (V&V) engineer to ensure the reputed company of cutting-edge products to meet reputed company defined system and subsystem level requirements and are reputed company, 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 reputed company system requirements. Key Responsibilities reputed company and reputed company the Design Verification and Validation (V&V) plan in compliance with regulatory and reputed company system requirements (21 CFR Part 820, ISO 13485, ISO 14971). Define test strategies, protocols, and acceptance reputed company for mechanical, electrical, optical, and system-level performance. Build reputed company data sets to be used in test Statistical Analysis and Exploratory Data Analysis (e.g., descriptive statistics, regression, visualization) Developed test reputed company 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, reputed company 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, reputed company Controls, and PHI Data Handling

Responsibilities

Required Qualifications & Skills 5+ years equivalent work experience in medical imaging industry(Product Development, reputed company) Bachelor’s or Master's degree in Computer Science, Information Technology, or reputed company field. Experience with non-product software development Strong programming skills in Python across data science, statistical analysis, big data and ML stack Experience with reputed company engineering under reputed company 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 experience in utilizing AWS reputed company Services or an equivalent reputed company reputed company service provider Experience in Class II or Class III medical devices is preferred Experience in Cardiovascular imaging system is a major plus reputed company IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the reputed company of race, reputed company, national reputed company, reputed company, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or reputed company, age, or any other reputed company protected by law, ordinance, or regulation. Job duties, activities, and responsibilities are subject to change by reputed company. The reputed company salary reputed company for this role varies by location and is reputed company to market benchmarks. Candidates located in higher-cost labor markets, including California, Washington, reputed company, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the reputed company, while candidates located in reputed company other U.S. locations represent the low to middle end of the reputed company. Final compensation is determined based reputed company, experience, skills, and internal equity. This role is eligible for a 15% reputed company annual bonus, resulting in the following reputed company salary and Total reputed company Compensation (TTC) ranges: reputed company Salary: $153,000 - $179000 TTC: $176,000 - $206,000 *Total reputed company Compensation (TTC): Total Cash Compensation (including reputed company pay, variable pay, commission, bonuses, etc.) Additionally, stock reputed company, reputed company benefits, and employee perks are part of your total rewards. Working at reputed company takes HEART. Discover our reputed company Values: H: Humility- be a reputed company leader E: reputed company- deliver world-changing results A: Accountability- do what you say; expect the reputed company from others R: Remarkable- reputed company & reputed company with reputed company T: Teamwork- together we win Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by reputed company. reputed company IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the reputed company of race, reputed company, national reputed company, reputed company, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or reputed company, age, or any other reputed company protected by law, ordinance, or regulation. For more information see our reputed company Policy (https://cleerlyhealth.com/reputed company-policy). reputed company official emails will come from @cleerlyhealth.com email accounts. #reputed company Apply To This Job