Field Clinical Engineer at BiVACOR Inc (United States)

BiVACOR Inc· United States·13h ago

Role details

Work type

Hybrid

Employment

Full-Time

Job description

Help Us Build the Future of the Human Heart.

At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every device you support, every team you train, and every urgent call you answer plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here.

About the Role

This is a high-impact, field-based engineering role at the frontier of Class III medical device technology, where your expertise will directly support patients implanted with the world’s first Total Artificial Heart. As a Field Clinical Engineer at BiVACOR, you will be the on-site technical authority, partnering with surgical teams, ICU staff, and hospital biomedical engineers to ensure safe, effective device operation from implant through long-term follow-up. You will bring sharp technical instincts, composure under pressure, and a commitment to excellence that helps move us closer to transforming care for patients with end-stage heart failure.

Key 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

What You Bring

Bachelor’s degree in Biomedical Engineering, Electrical Engineering, or a related field; advanced degree preferred
3–5+ years of field clinical engineering or field service experience in a Class II or Class III medical device environment
Prior experience with cardiac assist devices, ECMO, VAD, or implantable systems strongly preferred
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

What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

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 is a field-based role with extensive travel to implanting sites across the US and internationally. The expected salary range for this position is $130,000 to $180,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Why work at BiVACOR Inc

Mission-Driven Work: Employees directly contribute to a life-saving technology that addresses a critical global unmet need for patients with end-stage heart failure.
World-Class Team: Work alongside leading biomedical engineers and renowned cardiac surgeons, including pioneers in the field of artificial hearts.
Innovative Technology: Be at the forefront of a paradigm shift in artificial heart design, working with cutting-edge MAGLEV and rotary blood pump technology.
Culture: The company emphasizes collaboration, hard work, and recognizing team members. It is described as having a "highly driven and performing team" with a "robust collaborative network."
Remote/Hybrid/Office Policy: Not explicitly stated, but the company has multiple physical office locations (Huntington Beach, CA; Houston, TX; Gold Coast, Australia), suggesting an on-site or hybrid model is likely for engineering and lab roles.
Benefits & Perks:
- Health: Medical (HMO/PPO options with fully employer-funded premiums for some plans), Dental, Vision, Short-term & Long-term Disability.
- Time Off: Generous vacation (80 hours in year one, increasing to 136 hours by year 7) plus an additional 80 hours of PTO per year.
- 401(k): 4% non-elective employer contribution (immediately vested after 90 days) plus an elective employer match up to 6%.
- Incentives: Short-term and long-term incentive plans are part of the benefits package.
- Culture: Described as collaborative, hard-working, and focused on recognizing team members. The company is an equal opportunity employer committed to an inclusive environment.

About BiVACOR Inc

Company Overview

One-liner: BiVACOR is a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH) using magnetic levitation technology to replace both ventricles of a failing heart.
Entity Type: Private (Clinical-stage, Series B-III)
Headquarters: Huntington Beach, California, USA (with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia)
Founded: 2008
Founders: Daniel Timms, PhD (Founder & CTO)

Core Business

Primary industry: Medical Devices / Cardiovascular Therapeutics
Target customers: B2B (Hospitals, Cardiac Surgery Centers, Transplant Centers); End-users are patients with end-stage biventricular heart failure awaiting a heart transplant.
Mission or purpose statement: "Replacing Hearts. Restoring Lives." The company is committed to addressing the global unmet need of patients with end-stage heart failure by providing a next-generation, long-term life-extending solution.

Products & Services

BiVACOR Total Artificial Heart (TAH): A clinical-stage, implantable medical device designed to completely replace the function of both ventricles of a failing heart. It is a valveless, electro-mechanical rotary blood pump that uses a single, magnetically levitated (MAGLEV) rotor to pump blood to both the body and the lungs. The device is made of titanium, has no mechanical bearings or flexing diaphragms, and is designed to be compact, durable, and powerful (capable of flows over 12 L/min). It is intended as a bridge-to-transplant for patients with end-stage biventricular heart failure.

Market Standing

Valuation/Market Cap: Not publicly available (Private company).
Key Metric: Total funding raised is $59.75M (latest round: Series B-III of $9M, raised ~2 years ago). The company is currently conducting an FDA-approved Early Feasibility Study (EFS).
Notable Investors/Partners: Key partners include the Texas Heart Institute, Baylor St. Luke’s Medical Center, and St. Vincent’s Hospital Sydney. The company has received funding from various sources including an $18M round to move the TAH through first-in-human studies. The company has a robust collaborative network extending nationally and internationally.
Growth Signals: The BiVACOR TAH has been successfully implanted in five patients as part of an FDA Early Feasibility Study (EFS), with all five bridged to a donor heart transplant. The FDA has greenlit an expansion of the EFS to an additional 15 patients. The device was accepted into the FDA’s Total Product Life Cycle (TAP) Advisory Program. The first Australian implantation occurred in November 2024, with the TAH in place for over 100 days. The company received FDA Breakthrough Device Designation.

Competitive Advantages

Proprietary MAGLEV Technology: The BiVACOR TAH uses a single, magnetically levitated rotor with no mechanical bearings, valves, or flexing diaphragms, eliminating mechanical wear and friction. This is a fundamental design innovation compared to traditional volume-displacement TAHs.
Simple, Durable Design: The device has only one moving part (the rotor), which is suspended via magnetic levitation. This simplicity is a major differentiator, promising greater long-term durability and reliability.
Compact and Powerful: The TAH is designed to fit most men and women (BSA >1.4 m²) and can provide high flows over 12 L/min, sufficient for an adult male during exercise.
Regulatory Momentum: The device has received FDA Breakthrough Device Designation, is part of the FDA’s TAP (Total Product Life Cycle Advisory) Program, and has successfully completed a first-in-human Early Feasibility Study (EFS) with all five patients bridged to transplant. The EFS has been expanded to an additional 15 patients.

Strategic Focus

Clinical Validation & Regulatory Approval: The primary focus is on completing the expanded Early Feasibility Study (EFS) and progressing toward a pivotal study and eventual FDA premarket approval (PMA).
Global Expansion: Following successful implants in the US and Australia, the company is building a global footprint and clinical evidence base.
Commercialization Preparation: With the appointment of a new CEO (Jim Dillon, a veteran medical device executive) and acceptance into the FDA’s TAP program, the company is preparing for eventual commercialization and market entry.

Sources