Field Clinical Engineer
About the job
- A bachelor's degree in Biomedical Engineering, Electrical Engineering, or a related field is required.
- Three to five or more years of field clinical engineering or field service experience in a Class II or Class III medical device environment is required.
- The candidate must be comfortable working in a clinical environment, including operating theatres and intensive care units.
- The candidate must understand FDA Quality System Regulation (21 CFR 820), ISO 13485, and medical device complaint-handling requirements.
- The candidate must be willing to travel extensively to implanting sites and be available for on-call urgent response as the company grows.
- Experience contributing to standard operating procedures, work instructions, or field support documentation in a regulated environment is required.
- Provide on-site technical and clinical support for patients implanted with the BiVACOR total artificial heart device.
- Train surgical teams, intensive care unit staff, and hospital biomedical engineers on device operation and troubleshooting.
- Conduct pre-implant readiness checks, provide intraoperative support, and conduct 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 standard operating procedures and training materials.
- An advanced degree is preferred.
- Prior experience with cardiac assist devices, extracorporeal membrane oxygenation, ventricular assist devices, or implantable systems is strongly preferred.
About the company
BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH) to replace a failing heart. The device is a compact, titanium implant that uses a single magnetically levitated rotor to pump blood to the lungs and the rest of the body, eliminating valves and mechanical bearings to reduce blood damage. It serves as a bridge-to-transplant and aims to become a long-term (permanent) alternative to heart transplantation. BiVACOR operates in the cardiovascular medtech space, pursuing regulatory approval through preclinical and clinical trials, including an FDA Breakthrough Device Designation and an Early Feasibility Study. Its strategy includes expanding from Australia to the US, securing funding, and advancing toward commercialization to address the large unmet need in end-stage heart failure.
Company Size
51-200
Company Stage
Grant
Total Funding
$46.7M
Headquarters
Huntington Beach, California
Founded
2008
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Simplify's Take
What believers are saying
- Five of five U.S. patients bridged to transplant by August 2025 without pump replacement.
- The 2026 clinical trial recruits four major centers: Duke, Banner, The Christ Hospital, Texas Heart.
- Australia’s MRFF and NIH grants fund wireless power development and clinical expansion.
What critics are saying
- The 15-patient expansion increases visibility; one stroke, hemolysis, or infection can halt approvals.
- Patients need anticoagulation, transplant eligibility, and chest fit; exclusions shrink the addressable pool.
- No commercial approval exists in 2026; late-stage trial failure would kill BiVACOR’s standalone thesis.
What makes BiVACOR unique
- BiVACOR’s single-maglev-rotor titanium TAH removes valves, bearings, and mechanical wear points.
- July 9, 2024 first-in-human implant and five-patient bridge-to-transplant run built credibility.
- FDA Breakthrough Device and TAP acceptance in 2025 signal unusually close regulator engagement.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account/Flexible Spending Account
- Life Insurance
- Employee Assistance Program
- 401(k) Company Match
- Paid Vacation