Sr. Engineering Manager (Clinical Labs - Clinical Insights)

Cleerly•Denver, CO

17h

About The Position

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.

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.
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.

Nice To Haves

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

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.