---
title: 'Director of Verification & Validation at BiVACOR Inc'
canonical: 'https://feeny.ai/job/director-of-verification-validation-bivacor-inc-huntington-beach-04c3k4gr3wcp'
type: 'job'
last_seen: '2026-09-13'
---

# Director of Verification & Validation at BiVACOR Inc

- **Company:** BiVACOR Inc
- **Location:** Huntington Beach, CA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-06-24
- **Last confirmed live:** 2026-09-13
- **Apply:** https://jobs.ashbyhq.com/bivacor-inc/d59daedf-c538-4e38-bee1-b9e4e5c70fc4

## 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 process you optimize, every validation you lead, and every engineer you mentor 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

The BiVACOR Director of Verification & Validation (DVV) will implement engineering objectives and initiatives related to the BiVACOR program to drive the product through clinical trial. The DVV will provide technical direction, guidance and support for engineering initiatives, staff, vendors, and external consultants, with a focus on directing the verification and validation (V&V) activities of the implantable components of the BiVACOR Total Artificial Heart (TAH). The DVV will consult with top management and make recommendations to progress the V&V of the implantable TAH. The DVV will create functional strategies, develop budgets, policies and procedures for the V&V activities of the implantable TAH. The DVV will be responsible for the implementation of CFR 820.30 – Section C - design control particularly as it applies to the V&V aspects of the implantable subsystems and will work with quality management to ensure compliance to the relevant quality standards and regulatory agencies. The DVV will be required to be hands-on to support team to manage external V&V activities, as well develop and review V&V documentation. The high-level responsibility of this position will require a broad knowledge and transparent decision making in different aspects of engineering, while maintaining a focus on V&V. The role requires the DVV to be hands-on with the engineering teams to lead, teach best-practice engineering development, and V&V into the TAH development cycle. The DVV will monitor metrics within the development to identify potential issues and concerns with performance, scalability and quality, and work with the team to devise plans so that the teams can tactically address problems in a timely and effective fashion. This role requires the authoritative management of the in-house and external V&V effort and external consultant assignments and vendors while transforming the project from the prototype stage to a clinical environment. BiVACOR is looking for a motivated people leader who is keen to contribute to this early stage and dynamic project. This role requires creativity and strong organizational talent. Being able to find optimized solutions in a multidisciplinary and dynamic development will be vital to the project's success.

## What You Bring

- Bachelor’s degree or higher in Engineering (Biomedical or Mechanical) – Required.
- 8+ years’ experience in Class III medical device V&V – Required.
- Experience in Medical Device Industry and knowledge of engineering design, test, and safety standards (IEC 60601-1, FDA Regulations, ISO 14708, ISO 13485, ISO 9001) – Required.
- Understanding of design controls, including design (customer and product) requirements, performance specifications, and V&V testing – Required.
- Start-up company experience - highly desirable.
- Strong technical writing ability for designing V&V protocols and reports – Required.

## 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 role is based on-site at BiVACOR’s Huntington Beach, California headquarters and reports to the Manufacturing Engineering Manager. The expected salary range for this position is $180,000 to $230,000. 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.

## 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.

## Why Work Here
- **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.

## Sources
1. [bivacor.com](https://bivacor.com/)
2. [bivacor.com/careers](https://bivacor.com/careers/)
3. [bivacor.com/news](https://bivacor.com/news/)
4. [cbinsights.com](https://www.cbinsights.com/company/bivacor)
5. [jobs.ashbyhq.com](https://jobs.ashbyhq.com/bivacor-inc)

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