Biomedical Engineer with 4 years experience in a wide variety of cardiac medical devices mainly in cardiac leads.
• A solid experience with implantable Cardiac Defibrillators (ICDs), pacemakers, and cardiac leads.
• International Clinical project manager: planning, cost, to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees.
• Core teams clinical leader on cardiac leads by participating to the specifications and validation as well as all the aspects of the process development needed to develop new products.
• Responsible for ensuring compliance with all federal, local and company regulations, policies and procedures for health, safety and environmental compliance (ICH/GCP)
• Participate to clinical validation of the device: write the clinical protocol and clinical reports
• Support of Investigational Device Exemption (IDE)/ PreIDE
Mes compétences :
Chef de projet
Recherche
Recherche clinique