Full-Time
Quality Control Inspector
BiVACOR
51-200 employees
Develops magnetically levitated total artificial heart
Compensation Overview
$22 - $35/hr
Huntington Beach, CA, USA
In Person
Relocation benefits are not available.
 Manufacturing Quality & Test (1) |
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- IPC-A-610 Certification or IPC-A-620 Certification is required.
- Experience in a medical device FDA-regulated environment is required.
- At least 5 years of quality inspection experience in electronics or electromechanical work is required.
- Strong understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485 is required.
- Experience performing incoming, in-process, and final inspection of electronic and electromechanical components in an FDA-regulated medical device manufacturing environment is required.
- Willingness to work overtime and occasional weekends as needed is required.
- Ability to collaborate and communicate effectively is required.
- Inspect PCBAs, wire harnesses, and electronic assemblies.
- Conduct electrical testing, including continuity, insulation resistance, and Hi-Pot testing.
- Verify compliance with IPC-A-610 and IPC-A-620 standards.
- Review work against engineering drawings and specifications.
- Document inspection results in accordance with FDA and ISO 13485 requirements.
- Identify, document, and escalate non-conformances.
- Support continuous improvement within Quality and Manufacturing.
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
Houston, Texas
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
Growth & Insights and Company News
6 month growth
↓ -6%1 year growth
↓ -5%2 year growth
↓ -10%May 30, 2025 - BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The Texas Heart Institute, in collaboration with BiVACOR(R), has made a historic stride in cardiac care with the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH).
GOLD COAST, Australia HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR®, a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements. Led by Monash University, the AHFP is comprised of a consortium of research centers in Australia in collaboration with BiVACOR. The $13 million (USD) grant comes from a larger $50 million (AUD) grant from the MRFF to the AHFP to develop and commercialize devices to treat the most common forms of severe heart failure and bring new solutions to underserved patients. The award will support clinical work of the BiVACOR Total Artificial Heart (TAH) and begin development for the integration of wireless power sources for the device
Jim Dillon, a longtime executive in the medical device sector, has been hired to lead BiVACOR and join its board of directors.
At the same time, Bivacor also received $3 million in Small Business Innovation Research grant funding from the National Heart, Lung, and Blood Institute at the U.S. National Institute of Health.