Principal Design Quality Engineer

Cleerly is a healthcare company revolutionizing heart disease diagnosis and treatment. The Principal Design Quality Engineer will ensure compliance with quality management systems and regulations for software medical devices, contributing to the safety and efficacy of Cleerly's products.

Responsibilities:

• Act as the design quality engineering lead on software development project teams, providing guidance and oversight to ensure compliance with the Quality Management System (QMS) and external regulations
• Review and approve design and development documentation, including user needs, requirements specifications, software architecture, and verification & validation (V&V) plans, protocols, and reports
• Ensure all design control activities are compliant with ISO 13485, IEC 62304, and FDA 21 CFR Part 820
• Facilitate, document, and maintain risk management activities according to ISO 14971 throughout the product lifecycle, from initial concept through post-market surveillance
• Collaborate with engineering teams to ensure test methodologies are robust, effective, and well-documented for verifying and validating the software medical device
• Maintain the Design History File (DHF) for assigned projects, ensuring they are complete, accurate, and ready for audits and regulatory inspections
• Provide quality oversight for the software development lifecycle (SDLC) within an agile development environment, ensuring quality is built into the process
• Participate in design reviews, technical reviews, and other project meetings to ensure quality considerations are addressed and integrated
• Participate in software issue triage to determine risk of issues to the medical device and aid in development prioritization
• Support the investigation of design-related complaints and contribute to Corrective and Preventive Action (CAPA) activities as required
• Team leader who, in conjunction with management, designs and drives team-wide and company-wide training in the above areas

Requirements:

• Bachelor's degree in engineering, computer science, or a related engineering discipline
• 12+ years of experience in a Design Quality or Quality Engineering role within the medical device industry, with a strong focus on software as a medical device (SaMD)
• Excellent analytical and problem-solving skills with a high degree of attention to detail
• In-depth, practical knowledge of ISO 13485, with extensive experience in Product Realization processes
• Proven experience applying IEC 62304 (Medical device software - software life cycle processes) and ISO 14971 (Application of risk management to medical devices)
• Strong understanding of FDA Quality System Regulation (21 CFR Part 820) and familiarity with other global medical device regulations (e.g., EU MDR)
• Hands-on experience with modern software development and testing tools such as GitHub for source control, TestRail for test case management, and CI/CD pipelines
• Strong written and verbal communication skills, with the ability to work effectively in cross-functional, remote teams
• Travel to Cleerly's office locations is expected (Denver, New York) approximately twice per year
• ASQ certification (e.g., CSQE, CQE) is a plus