[Remote] Sr. Engineering Manager (Clinical Labs - Clinical Insights)

Note: The job is a remote job and is open to candidates in USA. Cleerly is a healthcare company revolutionizing heart disease diagnosis and treatment. They are seeking a Senior Engineering Manager to lead the engineering team in developing FDA regulated medical device software, ensuring compliance and collaboration with clinical and regulatory teams.ResponsibilitiesLead 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 standardsDrive decomposition of clinical and regulatory product requirements into actionable technical designs and software featuresManage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflowsCollaborate with AI/ML teams to integrate validated algorithms into the clinical product, ensuring regulatory compliance, performance, and usabilityEnsure compliance with cybersecurity, HIPAA, and FDA guidance for medical device softwareDefine and contribute to agile practices tailored to regulated environments, including CI/CD with validated pipelines and automated testing under design controlsPartner closely with product managers, radiologists, and data scientists to ensure clinical accuracy and usability of solutionsOversee risk management activities, including software hazard analysis and mitigationParticipate in cross-functional design reviews, regulatory audits, and technical file preparationRecruit and onboard top engineering talent with experience in healthcare and regulated domainsSkillsBachelor'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 rolesDemonstrated experience in medical device software development or healthcare technology, ideally with FDA 510(k) submissions or CE markingStrong programming skills in Python, TypeScript/JavaScript, Node.js, React, and SQL/NoSQL databasesExperience developing and securing RESTful and GraphQL APIsFamiliarity 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 monitoringDeep understanding of medical imaging (DICOM, PACS, cardiac CT) is a strong plusKnowledge of IEC 62304, ISO 14971 (risk management), ISO 13485 (QMS) and other regulatory frameworksExcellent verbal and written communication skills for both technical and clinical audiencesAbility to thrive in a fast-paced, startup-like environment while maintaining regulatory disciplinePassion for mentoring engineers and advancing clinical innovation in cardiovascular careBenefitsThis role is eligible for a 15% target annual bonusStock options, paid benefits, and employee perks are part of your total rewardsMost 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 locationTravel 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 timeCompany OverviewCleerly is a digital healthcare company that offers heart disease diagnosis solutions. It was founded in 2017, and is headquartered in Denver, Colorado, USA, with a workforce of 201-500 employees. Its website is https://cleerlyhealth.com/.Company H1B SponsorshipCleerly has a track record of offering H1B sponsorships, with 1 in 2026, 2 in 2025, 2 in 2024, 1 in 2023, 1 in 2022, 3 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.