Field Clinical Engineer

About the Company

BiVACOR is developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world.

Responsibilities

• 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
• Contribute to the development and refinement of field support SOPs and training materials

Requirements

• 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
• Strong understanding of FDA QSR (21 CFR 820), ISO 13485, and medical device complaint handling
• Willingness to travel extensively to implanting sites
• Availability for on-call urgent response

Preferred Qualifications

• 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