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Field Clinical Engineer Mitral EMEA Job

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Date: Jan 12, 2021

Location: Ratingen, NW, DE

Company: Boston Scientific

Additional Locations: France-Voisins le Bretonneux; Germany-Ratingen; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About this role:

Provide day-to-day field clinical study, technical/application and education support, site management, coordination and training for the Transcatheter Mitral Valve repair/replacement (TMVR) clinical programs. Promote clinical programs through education of current and new investigators by providing clinical strategy and case support to achieve company objectives. This will be primarily EU based but may include responsibilities and travel in the US and Australasia regions.

 

Location: This role can be based in one of our HUB locations (UK, Germany, Italy, Spain, France)

 

Your responsibilities will include:

Clinical Role -

  • Assist in the site selection, qualification, and initiation processes for clinical trials globally. Support Clinical department, Clinical Research Associates (CRA – Monitors and technical support) in ensuring and documenting clinical site and investigator readiness for participation in an investigation trial.
  • Key contact with the physicians and the research team during the patient screening and enrollment for clinical investigation, providing the support needed to collect all required screening materials for review by the assigned review committee and/or the sponsor.
  • Assist the Clinical department and the hospital research team during the conduct of the study, as well as after the clinical procedure, in all study-required data collection, including but not limited to adverse and serious adverse events reporting, source data collection, CT and echocardiographic images, etc.
  • Device Management: Monitor inventory levels, initiate logistics, i.e. shipments and movement tracking of investigational products according to regulatory and company guidelines. Monitor the levels and expiration dates of investigational product in the field. Coordinate communication between internal and external customers to facilitate return of product according to departmental SOP.
  • Ensure clinical trials are compliant to regulatory and company guidelines.
  • Supports company goals and objectives, policies and procedures, Good Clinical Practices and regulatory agencies regulations.
     
    Education/Training Role -
  • Will be responsible for the development and delivery of physician training plans/materials. This includes but is not limited to: hands-on training such as simulated procedures and SIM models, as well as training materials development and preparation. Presentation of didactic sessions, study cases and other training-related presentations at investigator and research coordinator meetings, and other training events.
  • Educate and train physicians, hospital personnel and hospital staff on technical matters relating to the company products by conducting and/or coordinating one-on-one training sessions, in-service education programs, and seminars and/or outside symposiums. Provide training and resources for hospital staff to enable them to conduct training for their personnel ("train the trainer").
  • Educate and train internal BSC employees in all functions as required.
     
    Technical/Engineering Role -
  • Assist in the clinical study procedure (sterile field), playing a key role in:
    • Millipede TMVR device preparation & case support
    • Acurate Neo device preparation & case support
    • Ancillary Products preparation & case support (Sentinel, Introducer sheaths, guide wires etc.)
  • Provide technical support and device and system troubleshooting as needed. Key role in maintaining compliance for peri-procedural data capture (images, steps of device delivery and performance, operators’ feedback, etc.) during the study procedure, enabling close monitoring of the device performance and procedural enhancement through constant communication with the field engineers.
  • Responsible for the development of the internal case summary reports template as well as their completion.
  • Work closely with the in-house engineers, participating in regular on-site training on the design implementation of the device, as well as any changes related to the design. Communicate design changes to the field as appropriate.

 

 

What we’re looking for in you:

Minimum Qualifications

  • Bachelor Degree and higher in Engineering, Sciences, Nursing or equivalent
  • 8 + years Clinical Research experience including coordinating multi-center trials and/or significant experience in the structural heart field with established technical expertise and knowledge
  • 3+ years Structural Heart experience (TAVR, Mitral, LAAC)
  • Experience in presenting, writing and teaching clinical and medical information
  • Experience with group presentations and hands-on experience with interventional/surgical cardiac procedures
  • Ability to travel approximately 75% - including International Travel
     
    Preferred Qualifications
  • Previous TMVR/Tricuspid experience preferred
  • Experience with ECHO imaging of the Mitral Valve
  • Experience using CT segmentation & analysis software (3Mensio or other)
  • Experience with Trans-septal procedures including TMVR or LAAC
  • Excellent written and verbal communication skills, very strong interpersonal skills including proficiency in medical terminology
  • Clinical Research experience in Medical Device
  • Experience coordinating multi-center Cardiology trials
  • Knowledge of Good Clinical Practices and ICH Guidelines and compliance for clinical trials
  • Personal computer skills, including proficiency in word processing, spreadsheet and computer database skills
     

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 472413

 


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