Consultant, Sr. Field Clinical Engineer

Responsibilities

• Serve as the clinical and device technical expert partnering with investigators and study site personnel to ensure high quality clinical cases in compliance with protocol, GCP, IFU, and industry standards.
• Collaborate with Clinical Operations to support study conduct at sites in compliance with protocol, SOPs, regional regulations, and GCP.
• Support study site personnel training on clinical and technical use of the study device per protocol and IFU.
• Manage site communication for case scheduling.
• Collaborate with Clinical Operations on clinical study data compliance at study sites.
• Collaborate with R&D on product development, pre-clinical evaluation, and clinical development of investigational devices.
• Collaborate with Clinical Scientists on protocol development to ensure alignment with clinical practice and device use.
• Collaborate with Regulatory and Quality Affairs on evaluation of device observations, engineering reviews, and post-market product complaints.

Requirements

• 3 to 5 years of experience supporting electrophysiology cardiac ablation cases.
• 2 or more years supporting investigational and post-market clinical studies.
• Positive relationships with study sites supporting EP clinical studies in the United States and/or European Union.
• Working knowledge of GCP for clinical trials.
• Ability to work in a fast paced dynamic setting.
• Ability to lift objects under 30 kg.
• Excellent interpersonal, organizational, and critical thinking skills; able to interface with key opinion leaders in electrophysiology.
• Positive, self-motivated, creative, detail-oriented team player.
• Willingness to travel up to 80% domestically and 20% internationally.

Qualifications

• BS or MS in Engineering, Biology, health, medical, or clinical sciences such as Physiology or Nursing.