Senior Field Clinical Engineer
Fully Remote Valencia, CA
Job Type
Full-time
Description

The Senior Field Clinical Engineer (Sr FCE) is responsible for proctoring implant procedures, providing ongoing training to surgeons and clinical sites on the use of the SetPoint system in accordance with the Instructions for Use and building effective relationships between paired rheumatologists and surgeons. The Sr FCE in collaboration with the Clinical Research Associate (CRA) supports assigned clinical sites during study start-up activities, site initiation visits, and follow-up visits. The Sr FCE will report to the Sr Manager, Clinical Operations. 


Job Responsibilities 

Include but are not limited to the following:


  • Support implant procedure, programming, troubleshooting, and complaint reporting at clinical study sites to ensure optimal system performance and maximum patient safety
  • Demonstrate outstanding product knowledge and train physician investigators and their support team on the SetPoint System
  • Provide feedback from cases and assist in developing future training materials and presentations for surgeons and site personnel
  • Assist with site selection by identifying and paring rheumatologists with surgeons
  • Support site qualification, initiation and monitoring activities
  • Create clinical study materials, such as presentations, work instructions and product training
  • Review source documentation and data reports for accuracy and completeness and assist with management of investigational product accountability
  • Ensure proper reporting of adverse events, protocol deviations, and device deficiencies and escalate to management in a timely manner as applicable
Requirements

Minimum Qualifications

  • Bachelor's or master’s degree in Biomedical Engineering or an equivalent scientific discipline, with a minimum of 5 years of directly related experience with active implantable devices and therapy programming
  • Proven experience developing and maintaining strong relationship with physicians and their practices
  • Practical knowledge of engineering principles, human anatomy, physician and hospital practices, and operating room etiquette 
  • Experience with neurological active implantable devices and working with neurosurgeons is strongly preferred 
  • Prior experience providing didactic or in vivo surgical training
  • Experience conducting clinical trials with medical devices 
  • Knowledge of Good Clinical Practice
  • Ability to fulfill and maintain background and health requirements necessary to gain access to clinical study centers, including operating rooms
  • Motivated self-starter with ability to work independently and collaboratively in a diverse cross-functional team environment
  • Excellent verbal and written communication, presentation and training skills 
  • Ability to think quickly on your feet and respond to needs as they arise 


Other Requirements

  • The position may require travel 60-70% of the time, with periods of more frequent travel (up to 90%)


Location 

This is a field position, requiring occasional visits to company headquarters in Valencia, CA.