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Field Clinical Engineer - Bioelectronics (Reversing Blindness)

Company: MedTech Startup
Location: Raleigh
Posted on: October 12, 2019

Job Description:

YOUR APPLICATION WILL NOT BE REVIEWED IF A CV/RESUME IS NOT ATTACHED All details will be shared via e-mail and phone after we receive your CV/resume. About Us: Pixium Vision is a publicly-traded, bioelectronic, brain-machine interface (BMI), clinical trial-stage startup with a mission to reverse blindness.-- Pixium Vision is developing innovative Bionic Vision Restoration Systems (VRS), which are active implantable medical devices intended to treat blindness resulting from the degeneration of retinal photoreceptor cells. These devices are intended for blind patients whose optic nerve remain functional. We are progressing towards our Early Feasibility Studies (EFS) in the United States following our 5 successful clinical implants in Europe.---- We are hiring our first U.S. Field Clinical Lead to report into the Head of Clinical Affairs and be part of a clinical team that is executing on multiple global studies (U.S. and EU). Realistically, this is a clinical professional with therapy development and Class III implantable medical device experience that can be successful in an entrepreneurial/startup environment. -- Our -50 employee bioelectronic--startup is headquartered in Paris, France. We have positive clinical data after successfully implanting our first-generation implant into 5 patients in Europe and our US early feasibility study is on track for Q1 2020. Here is the problem we are trying to solve with this position... Responsible for patient treatment follow-up-- KOL and clinical investigator development and management Provide clinical feedback and drive patient recruitment activities Clinical proctoring and case support for Feasibility studies in the U.S.-- Negotiate Clinical Trial Agreements (CTAs) and Fee Agreements with investigational sites Provide direct consultation to clinicians during device implantation and programming procedures Physician training and education - Train surgeons, nurses, and the surgical staff on surgical implantation procedure and device programming sessions Clinical study management of regional investigational sites, requiring a close working relationship with principal investigators and research coordinators Field Clinical Engineering management activities for this bioelectronic and brain-machine interface (BMI) start-up's implantable device at leading ophthalmic hospitals in the U.S. What does this position look like?... Based in the U.S. (remote) Reports to Head of Clinical Affairs This is a permanent, full-time position Ability to work with ophthalmic physicians Ability to travel as needed (including internationally) Ability to grasp (Class III MedTech) technology quickly Startup personality - "do what it takes" "Roll-up your sleeves" - Opposite of corporate ----All details will be shared via e-mail and phone after we receive your resume.

Keywords: MedTech Startup, Raleigh , Field Clinical Engineer - Bioelectronics (Reversing Blindness), Healthcare , Raleigh, North Carolina

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