Senior Manager, Engineering

Cleerly is a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We're seeking an Engineering Manager, Software to assist with the development of the next generation healthcare diagnosis system.

Requirements

• 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
• 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

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance