Senior Field Clinical Engineer

SetPoint Medical

Valencia, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/02/2021
  • Website: setpointmedical.com
  • Company Address: 25101 Rye Canyon Loop, Valencia, CA, 91355

About SetPoint Medical

SetPoint Medical is developing novel bioelectronic medicine therapies to treat those who suffer from autoimmune diseases such as rheumatoid arthritis, Crohn's Disease and multiple sclerosis. The company has developed a proprietary and innovative bioelectronic medicine platform consisting of a micro-regulator programmed via a unique prescription pad based interface. This novel therapy has the potential to provide patients and healthcare providers with a safe and efficacious alternative to drugs, while costing payers significantly less than biologic therapies.

Job 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

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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.