Engineering/ Manufacturing Tech

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. If that’s the kind of work that gets you out of bed in the morning, we think you belong here.

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.

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.

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.

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

A working knowledge of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations.

Medical, dental, and vision insurance

Health Savings Account (HSA) & Flexible Spending Account (FSA)

Life insurance & Employee Assistance Program

This role is based on‑site at BiVACOR’s Huntington Beach headquarters. A discretionary annual bonus may be available based on individual and company performance. Relocation benefits are not available for this posting.

We celebrate diversity and are committed to creating an inclusive environment for all employees.

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