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Medical Device Technical Specialist – Active DevicesCompany BSI
Location Herndon, VA
Update 6 Day ago
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.
Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists within the Active 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 across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.
We currently have an exciting opportunity in our Global Medical Devices team, working as a Technical Specialist within the Active Devices team. This role is homebased and you can be located in either the UK, France, Germany, Spain, the Netherlands, or Italy.
About the Role 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.
About You To be successful in this role you will need to apply the significant knowledge and ‘hands on’ experience that you have gained in research, design and development of medical devices, including the application of the principles of design control, risk management and performance or clinical evaluation.
The right candidate will have demonstrated strong inter-personal and communication skills, as well as a track record in project or programme management.
The role requires you to have a solid foundation of experience in the design, development and manufacturing of Active Devices devices including, e xperience in electro-medical device technical development or testing & at minimum an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971.
You’ll also hold a BSc, Master’s degree or PhD (or equivalent qualification) in Physics, Electrical Engineering, Biomedical Engineering or closely related subject.
What we offer:
We offer a highly competitive starting salary of up to £60,000/€72,000 (depending on experience) plus 10% to 15% bonus (depending on location). BSI also offers employees a wide range of flexible benefits that you can tailor to suit your life-style.
We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers. As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.