--- title: 'Manufacturing Engineer III at BiVACOR Inc' canonical: 'https://feeny.ai/job/manufacturing-engineer-iii-bivacor-inc-huntington-beach-kd20ph98pjha' type: 'job' last_seen: '2026-09-13' --- # Manufacturing Engineer III at BiVACOR Inc - **Company:** BiVACOR Inc - **Location:** Huntington Beach, CA - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-06-23 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.ashbyhq.com/bivacor-inc/7b744baf-93a4-4e4f-8910-e54023a66112 ## 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 part you track down, every work order you keep moving, and every schedule you protect 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 Manufacturing Engineer III plays a crucial role in developing, optimizing, and implementing efficient and scalable manufacturing processes for the BiVACOR total artificial heart (TAH). This position focuses on integrating value engineering principles, ensuring high-quality, cost-effective manufacturing while maintaining regulatory and performance standards for implantable components. The Manufacturing Engineer III collaborates with engineering teams, management, and external vendors to improve tooling and component quality, evaluate cost-reduction strategies, and implement process improvements that enhance the long-term viability and manufacturability of the device. The role involves testing, troubleshooting, and optimizing production processes to ensure product conforms to specifications. ## Key Responsibilities - Design, develop, and improve manufacturing processes to enhance efficiency and product quality. - Implement Lean and Six Sigma methodologies to reduce waste and optimize workflows. - Implement automation and advanced manufacturing techniques where applicable. - Design, procure, and validate equipment, tools, and fixtures for manufacturing processes. - Ensure proper calibration and maintenance of manufacturing equipment. - Conduct process validations (IQ, OQ, PQ) and ensure compliance with FDA, ISO 13485, and GMP standards. - Support NC/CAPA investigations and implement corrective actions. - Create and maintain manufacturing documentation, including BOMs, work instructions, and process flow charts. - Prepare technical reports and documentation for audits and regulatory submissions. - Analyze and resolve manufacturing issues, including CAPAs and non-conformances. - Identify opportunities for process improvements and implement solutions to enhance productivity and reduce costs. - Work closely with cross-functional teams, including R&D, Quality Assurance, and Supply Chain, to support product development and manufacturing goals. - Provide technical support to production teams and train operators on new processes and equipment. ## What You Bring - BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering, MS desirable (or equivalent) - 5+ years engineering experience including skills in process development, Manufacturing Engineering and industrialization preferably in the medical device industry or other highly regulated industry - Expert in process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs. - A working knowledge of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations. - Working knowledge of industry best practices and applicable standards. - Advanced problem-solving (Six Sigma Green / Black Belt) ## 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 headquarters. The expected salary range for this position is $120,000 to $127,000. 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. 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