Principal Design Quality Engineer
Lead software design quality activities ensuring ISO 13485, IEC 62304, and FDA 21 CFR Part 820 compliance for SaMD.
- Remote
- Full Time
- $145,000 – $160,000/year
- Min. 12 YOE
Browse the full live job inventory for Cleerly. This page is focused on current openings, while the overview tab highlights role groups and hiring patterns.
Lead software design quality activities ensuring ISO 13485, IEC 62304, and FDA 21 CFR Part 820 compliance for SaMD.
Lead design and validation of clinical workflow integrating AI for cardiac imaging and collaborate with academia to advance cardiovascular AI.
Strategic regulatory leadership to enable AI-enabled medical devices with global expansion and governance.
Imaging integration backend engineering to connect hospital systems, DICOM and cloud endpoints for an enterprise imaging platform.
Supports imaging site education and training, on-site/virtual visits, and CT vendor collaboration to improve imaging quality.
Lead the development and launch of AI-powered cardiovascular products with cross-functional teams and clinical focus.
Owns scalable AI services and computational imaging pipelines, ensuring compliant, high-availability systems for regulated AI in medical imaging.
Lead design and validation of innovative clinical workflow for AI-driven cardiac imaging with collaborations across academia and industry.
Clinical account management role supporting clinical partners to drive Cleerly adoption and education for cardiovascular diagnostic technology.
Lead the release and launch of AI-powered cardiovascular health products with cross-functional collaboration.
Develop experience in planning and operationalizing daily schedules to accomplish targets in a remote-friendly, growing AI-healthcare environment.
Own regional sales to health systems and providers, managing high-value portfolio and driving cross-sell opportunities.
Senior ML software engineer to design, deploy, monitor, and optimize production-ready ML services in regulated healthcare.
Senior Quality Engineer responsible for maintaining and confirming the quality of Cleerly’s products, ensuring compliance with company requirements, international standards, and federal regulations.
Lead product realization in regulated SaMD, coordinating cross-functional teams to ensure compliant, high-quality, timely delivery.
Architect scalable ML platforms and end-to-end pipelines for production in regulated healthcare environments.
Regulatory strategy execution for AI/ML-enabled medical devices across global markets with submissions and compliance.
Leads engineering teams to deliver FDA-regulated SaMD with AI/ML integration and regulatory compliance.
Senior Software Engineer designs, builds, deploys, and optimizes production-ready ML services in regulated healthcare with CI/CD and MLOps practices.
Lead the design lifecycle for referring physician experience, turning complex analytics into scalable dashboards and user-friendly workflows.
Develop scalable backend services and user-facing applications for an enterprise-grade platform in a healthcare context.
Drive development and translation of ML models for heart disease diagnosis and prognosis.