Manufacturing Engineering Manager

The Manufacturing Engineering Manager is a key technical leader responsible for establishing and scaling BiVACOR's manufacturing capabilities to support the development and commercialization of its implantable artificial heart system. This role oversees the design, validation, and continuous improvement of manufacturing processes, equipment, and infrastructure to ensure the reliable, compliant, and cost-effective production of Class III medical devices.
Working cross-functionally with R&D, Quality, Regulatory, and external partners, the Manufacturing Engineering Manager drives the transition from prototype to scalable production, implements lean manufacturing principles, and ensures alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable standards. The role also leads the development of manufacturing documentation, supports supplier qualification, and mentors a growing team of engineers and technicians in a fast-paced, innovation-driven environment.
This position plays a critical role in translating engineering excellence into a manufacturable reality—ensuring that every device produced meets the highest standards of safety, performance, and reliability for patients worldwide.
Key Responsibilities
General
Lead process development and manufacturing engineering to complete design transfer from R&D to manufacturing.
Lead upscaling in manufacturing to ensure sufficientcapacity.
Lead Design for Manufacturability initiatives. This includes working closely with the product development team and the quality team.
Implement meetings as needed and regularly report progress.
Ensure compliance with relevant standards and best practices in all aspects of manufacturing, including GMP, QSR, and ISO 13485.
Manage and mentor a team of manufacturing engineers
Ensure that the necessary resources are allocated to meet the company's goals and objectives.
Manufacturing
Design, develop, qualify, and implement manufacturing processes for new product introductions
Lead manufacturing scale-up efforts, including capital equipment procurement
Implement processes to improve design for manufacturability and assembly
Lead remediation of poor manufacturing outcomes
Establish process qualification to ensure a compliant product
Support qualification of suppliers to ensure conformance of supplied products and services to product specifications.
Operational Excellence & Continuous Improvement
Implement manufacturing improvements to increase product yield and decrease the cost of goods supplied (COGS).
Implement manufacturing improvements to ensure safe and ergonomic manufacturing operations.
Cross-Functional Leadership & Collaboration
Serve as a member of the Operations leadership team, contributing to Manufacturing Strategy planning and decision-making.
Collaborate closely with R&D, Quality, Operations, and Regulatory teams to align operations with business objectives.
Facilitate cross-functional initiatives for new product introduction (NPI), design transfer, and lifecycle management.
Risk Management & Business Continuity
Ensure that manufacturing capacity meets both short-term and long-term business needs under varying market conditions.
BiVACOR is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.
Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. Our highly driven and performing team has complementary science and business minds to focus on "Replacing Hearts and Restoring Lives."
Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us.
BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email .
Our Benefits and Perks Health and Welfare Medical Benefits – Numerous HMO and PPO options, several of which have monthly premiums fully employer funded.
Dental/Vision, Short-term & Long-term Disability also available at low employee cost.
Vacation and PTO BiVACOR also has very generous vacation and PTO policies. Vacation policy for first year employees is 80 hours per year. Increasing yearly up to 136 hours upon 7th year of employment. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year.
401(k) BiVACOR proudly offers both Non-Elective and Elective 401(k) plans.
Our Non-Elective 401(k) is a 4% employer only contribution, made on your behalf each pay period and immediately vested upon 90-day qualification.
Our Elective 401(k)-employer match is up to 6%. That means that for every dollar you contribute to your 401 (k), you will receive a matching dollar-for-dollar contribution in your account up to 6% of your pay.
Incentives Short-Term and Long-Term Incentives are also part of our current benefit package.
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