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Technical Specialist & Scheme Manager – Vascular Medical Devices

BSI West

This is a Contract position in Chicago, IL posted November 26, 2020.

Great that you’re thinking about a career with BSI!

BSI is a designated European Notified Body, an accredited ISO 13485 certification body, a recognized Auditing Organization under MDSAP, and we have an opportunity for you to join our growing team! 

We are seeking a Medical Device Technical Specialist with Vascular expertise in one of the following areas:

Electrophysiology Radiofrequency (RF) ablation catheters, mapping catheters, atrial fibrillation devices, cryoablation, ultrasound ablation, laser ablation, devices for diagnosing and treating cardiac arrhythmia

Neurovascular neurovascular stents, neurovascular catheters, embolization coils and catheters, flow diverters, vascular devices for treating strokes, clot retriever devices, thrombectomy devices, microcatheters, neurovascular occlusion balloons
 

Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety – this may be a great fit for you! This is a home-based position with up to 25% travel (when COVID-19 travel restrictions lift).

Essential Responsibilities:

  • Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management and ISO 13485 QMS assessment services.

  • Provide advice and support on certifications in area of expertise that may have a regulatory challenge.

  • Participate in client meetings to facilitate CE marking processes.

  • Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.

  • Provide “Technical Sales/Networking” support as needed

The ideal candidate will possess the following characteristics:

  • Bachelor’s degree or higher in a discipline relevant to medical device design, manufacture and use, or equivalent qualification.

  • At least five (5) years’ post-graduate experience in the design and development of vascular medical devices, including the principles of design control, risk management and performance and/or clinical evaluation

  • Knowledge of medical device regulations.

  • Awareness of certification business processes, the application of quality management standards, and audits 

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is an Equal Opportunity Employer and we are committed to diversity.

To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.

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