BSI Group

Medical Device Technical Specialist - Vascular Devices

Location(s) US-NC-Raleigh
Category
Healthcare
Contract Type
Perm Full-Time
Salary
Competitive salary plus bonus

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

We are seeking candidates with the following attributes/qualifications:

 

  • Bachelor's degree in Engineering or discipline relevant to medical device manufacture and use
  • At least five 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.
  • Demonstrated strong interpersonal and communication skills, as well as a track record in project or program management.
  • Solid foundation of experience in the design, development and manufacturing of one or more of the following Vascular Devices including:
    • stents and stent delivery systems, percutaneous heart valves, devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories) and have basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.

 

 

 

 

 

 

 

About BSI

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.   

 

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, 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 Vascular Devices team. This role is homebased with travel to client sites and training as needed.

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