Test Manager
CurrentTest Manager for the Ambu monitor products (displaying units) supporting the single-use endoscopes of the Ambu aScope series visualization devices. Test and verification management of medical devices including software, hardware, mechanics and system testing. Close collaboration with various parts of the organization from research and development to marketing, quality assurance and regulatory affairs. Daily work with a great team of colleagues responsible for management, tracking and reporting of testing progress and status to relevant stakeholders.Input to FDA 510(k) submissions and working with the regulatory frameworks of FDA Design Control (21 CFR 820.30) and ISO 13485.