Role & responsibilities Develop and execute comprehensive software V&V strategies, plans, and schedules for medical device software. Lead a team of engineers in performing software verification and validation activities. Ensure compliance with international standards (e.g., IEC 62304, ISO 14971) and regulatory requirements (e.g., FDA, MDR). Define software test requirements, test cases, and test protocols based on functional and design specifications. Perform hands-on testing, including manual and automated testing, to ensure product quality and performance. Analyse test results, identify defects, and collaborate with development teams to resolve issues. Author and maintain detailed V&V documentation, including test plans, test reports, and traceability matrices. Ensure software meets safety, usability, and cybersecurity standards. Support regulatory submissions by providing required V&V artifacts. Work closely with cross-functional teams, including software development, quality assurance, risk management, and regulatory affairs. Provide mentorship and training to junior engineers to build expertise in V&V practices. Preferred candidate profile Perks and benefits