The Field Clinical Engineer (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 FCE in collaboration with the Sr. FCEs and the Clinical Research Associate (CRA) supports assigned clinical sites during study start-up activities, site initiation visits, and follow-up visits. The FCE will report to the Manager, Field Clinical Engineering.
The candidate needs to be based in the Southeast United States.
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
- 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 Sr. FCEs with site selection by identifying and paring rheumatologists with surgeons
- Assist with management of investigational product accountability
- Support CRA with site qualification and initiation activities
- Ensure proper reporting of adverse events, protocol deviations, and device deficiencies and escalate to management in a timely manner as applicable
- Bachelor's or master’s degree preferred in Biomedical Engineering or experience in an equivalent scientific discipline, with a minimum of 3 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 physician and hospital practices and operating room etiquette
- Experience with neurostimulation active implantable devices is strongly preferred
- Prior experience providing didactic or in vivo surgical training
- Experience conducting clinical trials with medical devices
- 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
- The position may require travel 60-70% of the time, with periods of more frequent travel (up to 90%)
This is a field position, requiring occasional visits to company headquarters in Valencia, CA.
SetPoint Medical is a clinical stage medical device company developing the first implantable neurostimulation device for the treatment of autoimmune diseases.