Job Title:	Field Clinical Engineer (FCE)
Department:	Clinical Affairs
Job Reports To:	VP, Regulatory & Clinical Affairs
FLSA:	Exempt

 

Scope:

Working with the Clinical Engineering team in a collaborative and cross-functional setting, the FCE will participate with the clinical team in the management and execution of electrophysiology studies using the Company's unique Endoscopic Ablation System in the treatment of patients with atrial fibrillation (AF).

Responsiblilites:

• The primary responsibility is to ensure that high quality AF ablation clinical cases are performed during the Company’s clinical studies that comply with the clinical study protocol, industry standards and the company’s instructions for use (IFU)
• Investigator and study site personnel training on the use of the Company's products according to the study protocol, industry standards and the IFU
• Responsible for site communication for all device shipments and cases scheduling
  
• Verifying proper device shipment, accountability and disposition
• Support conduct of the clinical study in compliance with study protocol, SOP's, FDA guidelines and GCP Guidelines
• Collaboration with Clinical and Engineering Teams
• Support preclinical investigations
  

Requirements:

• BS in Biology, health, medical or clinical sciences (e.g., Physiology or Nursing)
• At least 2-3 years of hospital experience, ideally in the EP lab conducting ablations
• At least 2 years working for a medical device EP company supporting clinical cases of AF pulmonary vein isolation (PVI) ablation
• Working Knowledge of GCP's and FDA guidelines for clinical trials
• Ability to work in fast paced dynamic setting
• Excellent interpersonal, organizational, and critical thinking skills; able to interface with leading thought leaders in the field of AF ablation
• Positive, self-motivated, creative, detail oriented team player
• Travel: Up to 80%

 

Please submit your resume and cover letter to Burke Barrett at bbarrett@cardiofocus.com.