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 audits, and technical file preparation.

• Recruit and onboard top engineering talent with experience in healthcare and regulated domains. Requirements:

• Bachelor’s degree in Computer Science, Software Engineering, or related discipline (Master’s preferred).

• 8+ years of software engineering experience, including 2+ years in management/leadership roles.

• Demonstrated experience in medical device software development or healthcare technology, ideally with FDA 510(k) submissions or CE marking .

• Strong programming skills in Python, TypeScript/JavaScript, Node.js, React, and SQL/NoSQL databases .

• Experience developing and securing RESTful and GraphQL APIs .

• Familiarity with AWS cloud services and infrastructure-as-code (Terraform, CloudFormation).

• Experience integrating AI/ML algorithms into production healthcare or medical device software, including validation and performance monitoring.

• Deep understanding of medical imaging (DICOM, PACS, cardiac CT) is a strong plus.

• Knowledge of IEC 62304, ISO 14971 (risk management), ISO 13485 (QMS) and other regulatory frameworks.

• Excellent verbal and written communication skills for both technical and clinical audiences.

• Ability to thrive in a fast-paced, startup-like environment while maintaining regulatory discipline .

• Passion for mentoring engineers and advancing clinical innovation in cardiovascular care. The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets , including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.

• Final compensation is determined based on location, experience, skills, and internal equity. This role is eligible for a 15 % target annual bonus , resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $190,000 - $219,000

• TTC: $218,000 - $251,000 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

Working at Cleerly takes HEART. Discover our Core Values:

• H: Humility - be a servant leader
• E: Excellence - deliver world-changing results
• A: Accountability - do what you say; expect the same from others
• R: Remarkable - inspire & innovate with impact
• 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 our company.

OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

For more information see our Privacy Policy ( https://cleerlyhealth.com/privacy-policy) . All official emails will come from @cleerlyhealth.com email accounts.

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