Clinical Field Engineer

Company Overview:

AVS is an early-stage medical device company that is focused on safely and effectively treating severely calcified arterial disease. AVS is the first company to develop pulsatile intravascular lithotripsy (PIVL™), a therapy that is delivered through a balloon-based platform called the Pulse IVL™ System. It is designed to be the only minimally invasive technology that gently fractures calcium and opens the artery using a single device.

RESPONSIBILITIES:

Technical expertise:

• Provide technical support to the clinical teams including troubleshooting, devising workarounds, and escalating complex investigations for system issues in the field to the R&D team.
• Lead root cause investigation, troubleshooting, and investigation of field service issues using multiple tools and data sets, and by working directly with R&D team for problem resolution. Monitor and troubleshoot equipment performance.
• Effectively summarize, analyze, and draw conclusions from clinical use and feedback in the field. Work cooperatively with R&D, Process Development, Quality and Clinical teams.
• Ability to write and provide technical instructions.

Customer Focus: Represents AVS in front of leading cardiologists, interventionalist, and vascular surgeons to insure their understanding of the therapy.

Clinical Trial Management: Provides input into the development and implementation of clinical study documents, operational strategy and timelines for clinical research.

Clinical Site Support:

• Leading and supporting field activities for clinical research.
• Partners with all relevant individuals (e.g. principal investigators, cardiac clinicians, surgeons, research coordinators) at clinical research sites to facilitate site activation, enrollments, eligibility and follow-up visit compliance at clinical sites.
• Develops and manages all aspects of training related to the clinical research, including the clinical protocol, IVL procedure, and scheduling logistics.
• Provides support to clinicians at clinical research sites, including study and protocol questions, technical inquiries and researching solutions to questions or problems.
• Understand and incorporate the patient flow to support trial enrollment and screening.
• Delivers and manages training programs for other clinical staff ensuring that clinical training and study objectives are met. S
• Support Clinical Research function to ensure high quality follow-up and completeness of data for the Company’s studies.

REQUIREMENTS:

• Bachelor’s Degree: Engineering related field preferred
• Understanding of engineering principles, theories, concepts, practices, and techniques Proven track record in leading clinical sites and trials in a medtech company.
• 5+ years experience directly supporting clinical research as a technical expert in medtech
• Knowledge and experience with clinical program processes to include protocol development, execution, study report writing and regulatory submissions.
• Experience in working with vascular devices and procedures.
• Knowledgeable in FDA regulations, ISO 14155, MDR and GCP.
• Strong analytical skills with a data driven approach to planning, executing, and problem solving.
• Project management skills, cross-functional engagement and organizational skills.