BSI Group Medical Device Technical Specialist - Structural Heart in Rome, Italy
Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists within the Vascular Devices team. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients globally, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.
The Technical Specialist role is full-time, salaried and homebased with approximately 25% travel.
As the Technical Specialist you will be involved in the review and evaluation of your client’s medical device technical documentation and your opinion will influence which products go to market. You’ll be working with a variety of medical device manufacturers globally, managing a portfolio of product types, with a commitment to delivering a diligent and timely service.
The fast paced nature of this rewarding role will eventually require you to work autonomously with manufacturers as they execute their ‘go to market’ plans.
The role requires the Technical Specialist to be efficient and effective in; comprehending technical information, targeted questioning, forming opinions and offering recommendations. The role requires the Technical Specialist to provide a critical, but common sense, evaluation of the information provided by the manufacturer to demonstrate conformity with applicable regulations or standards.
Do you believe the world deserves excellence?
BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.
Bachelor's degree (or higher) in discipline relevant to medical device manufacture and use.
At least five (5) years of ‘hands on’ experience in research, design and development of medical devices, including the application of the principles of design control, risk management and performance or clinical evaluation.
Must have solid foundation of experience in the design, development and manufacturing of one or more of the following Structural Heart Vascular Devices: percutaneous heart valves, guide wires, mitral valve, transcatheter mitral valve repair (TMVR), transcatheter aortic valve implantation (TAVI), atrial septal defect (ASD), left atrial appendage (LAA) occluders, closure devices and related accessories.
Ability to travel up to 25% for trainings, meetings, and client visits.
Externally Advertised Salary: Competitive salary plus bonus
External Company Name: British Standards Institution, The