Software V&V Lead

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