Sr. Engineering Manager (Clinical Labs - Clinical Insights)

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. About the Opportunity Cleerly, Inc. is a technology-based healthcare company whose mission is to create digital care pathways to prevent heart attacks. Cleerly, Inc, in Denver, CO is seeking an Engineering Manager, Software to assist with the development of the next generation healthcare diagnosis system, with cutting-edge technologies. Job responsibilities and duties include: Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD) . Collaborate with clinicians, regulatory, and quality teams to ensure software development aligns with IEC 62304, ISO 13485, and other relevant standards . Drive decomposition of clinical and regulatory product requirements into actionable technical designs and software features. Manage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflows . Collaborate with AI/ML teams to integrate validated algorithms into the clinical product, ensuring regulatory compliance, performance, and usability. Ensure compliance with cybersecurity, HIPAA, and FDA guidance for medical device software . Define and contribute to agile practices tailored to regulated environments , including CI/CD with validated pipelines and automated testing under design controls. Partner closely with product managers, radiologists, and data scientists to ensure clinical accuracy and usability of solutions. Oversee risk management activities, including software hazard analysis and mitigation. Participate in cross-functional design reviews, regulatory aud