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.
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
Skills
- 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
Benefits
- This role is eligible for a 15% target annual bonus
- Stock options, paid benefits, and employee perks are part of your total rewards
- 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
- 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
Company Overview
Cleerly 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 Sponsorship
Cleerly 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.