Cleerly · 2 hours ago
Senior Manager, Engineering
Denver, CO
Full-time
Hybrid
Senior Level, Lead/Staff
$236K/yr - $281K/yr
8+ years expCleerly is a healthcare company focused on revolutionizing heart disease diagnosis and treatment. They are seeking a Senior Manager of Engineering to lead the software development lifecycle for FDA regulated medical device software, ensuring regulatory compliance and collaboration across various teams.
AppsArtificial Intelligence (AI)Health CareMedicalWellness
Responsibilities
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
Qualification
Required
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
Company
Cleerly
Cleerly is a digital healthcare company that offers heart disease diagnosis solutions.
201-500 employees
H1B Sponsorship
Cleerly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$386.48MKey Investors
Insight PartnersVensana Capital
2024-12-03Series C· $106M
2022-07-25Series C· $223M
2021-06-21Series B· $43M
Leadership Team
James Min
Founder and Chief Executive Officer
Jim Hartman
Chief Commercial Officer (CCO)
Recent News
2026-01-07
2025-11-27
Company data provided by crunchbase