The Principal Design Quality Engineer will be expected to contribute to maintaining the safety and efficacy of Cleerly’s software medical device products. You will be a key member of the product development team, ensuring that our software medical devices are developed in compliance with our ISO 13485 certified Quality Management System and applicable standards and regulations. 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.