Note: The job is a remote job and is open to candidates in USA. BiVACOR is developing the world’s most advanced total artificial heart, aiming to save millions of lives. The Field Clinical Engineer will provide technical support for the BiVACOR TAH device, ensuring its effective operation and training medical staff on its use.
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 within agreed response timeframes
- Contribute to the development and refinement of field support SOPs and training materials
Skills
- 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
- Advanced degree preferred
- Prior experience with cardiac assist devices, ECMO, VAD, or implantable systems strongly preferred
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
- This position also qualifies for the benefits detailed at the link provided below.
Company Overview
Company H1B Sponsorship