Bivacor Inc

Field Clinical Engineer

United States , Remote. Posted 5 months ago

The role

You will provide on-site technical and clinical support for patients implanted with the BiVACOR TAH device. You will partner with surgical teams, ICU staff, and hospital biomedical engineers to ensure safe device operation.

What you will do

  • Provide on-site technical and clinical support for patients implanted with the BiVACOR TAH device
  • Train surgical teams, ICU staff, and hospital biomedical engineers on device operation and troubleshooting
  • Conduct pre-implant readiness checks, intraoperative support, and post-implant follow-up at assigned sites
  • Document device performance, incident reports, and site interactions in the clinical database
  • Respond to urgent site calls and troubleshoot device-related issues within agreed response timeframes
  • Contribute to the development and refinement of field support SOPs and training materials

Required qualifications

  • Bachelor’s degree in Biomedical Engineering, Electrical Engineering, or a related field
  • 3–5+ years of field clinical engineering or field service experience in a Class II or Class III medical device environment
  • Comfortable working in a clinical environment including operating theatres and ICUs
  • Strong understanding of FDA QSR (21 CFR 820), ISO 13485, and medical device complaint handling requirements
  • Can-do attitude
  • Composure under pressure
  • Strong teamwork and communication skills
  • Willingness to travel extensively to implanting sites
  • Availability for on-call urgent response as BiVACOR grows
  • Experience contributing to SOPs, work instructions, or field support documentation in a regulated environment

Nice to have

  • advanced degree
  • Prior experience with cardiac assist devices, ECMO, VAD, or implantable systems

Benefits

  • 401(k) with company matching
  • Medical, dental, and vision insurance
  • Health Savings Account (HSA) & Flexible Spending Account (FSA)
  • Life insurance & Employee Assistance Program
  • Generous paid time off

About the company

BiVACOR is developing the world’s most advanced total artificial heart. The team is working on technology capable of saving millions of lives.