• 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.