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About the Role

Cleerly, Inc. is seeking an Engineering Manager, Software to assist with the development of the next generation healthcare diagnosis system, using cutting-edge technologies. This role is critical to achieving Cleerly's quality objectives in providing safe and effective medical software.

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.

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.

Skills

• Python
• TypeScript/JavaScript
• Node.js
• React
• SQL/NoSQL databases
• RESTful APIs
• GraphQL APIs
• AWS cloud services
• Infrastructure-as-code (Terraform, CloudFormation)
• AI/ML integration
• Medical imaging (DICOM, PACS, cardiac CT)
• IEC 62304
• ISO 14971
• ISO 13485
• Google Workspace (GMail, Drive, Docs, Sheets, Slides)
• Slack
• Confluence/Jira
• Zoom Video

Location

• Denver, Colorado
• New York, New York
• Dallas, Texas
• Lisbon, Portugal
• Remote

Work Type

• Remote
• On-site

Experience Level

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

Education Level

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

Salary/Compensations

• Base Salary: $190,000 - $219,000
• TTC: $218,000 - $251,000

Benefits

• Stock options
• Paid benefits
• Employee perks
• 15% target annual bonus

About the Company

• Cleerly is a healthcare company revolutionizing heart disease diagnosis, treatment, and tracking.
• Founded in 2017, Cleerly has raised significant funding to support its mission.
• Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions.
• The company's technology quantifies and characterizes atherosclerosis.
• Cleerly's solutions are supported by extensive clinical trials.
• Cleerly is committed to providing safe and effective medical software adhering to regulatory requirements.
• The company emphasizes continuous improvement, risk management, and compliance.
• Cleerly's core values are Humility, Excellence, Accountability, Remarkable, and Teamwork (HEART).

Equal Opportunity

• Cleerly 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.