Manufacturing Engineer III

BiVACOR Inc; Huntington Beach (CA); On-site; USD 120,000 - 127,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision insurance

Health Savings Account (HSA)

Generous paid time off

Job summary

BiVACOR Inc is seeking a Manufacturing Engineer III to develop manufacturing processes for the total artificial heart. The role involves process improvement, ensuring regulatory compliance, and optimizing product quality.

Qualified candidates will have a BS in engineering, 5+ years of relevant experience, and expertise in Lean and Six Sigma methodologies. This position offers a competitive salary, benefits, and the opportunity to make a significant impact in the medical device industry.

Qualifications

• 5+ years engineering experience including skills in process development and industrialization preferably in medical device industry.
• A working knowledge of medical device quality regulations such as ISO 13485 and FDA requirements.
• Expert in process characterization and advanced problem-solving.

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.
• Conduct process validations and ensure compliance with FDA and ISO standards.

Skills

Process development

Manufacturing Engineering

Problem-solving

Lean methodologies

Six Sigma

Education

BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering

MS desirable or equivalent

Tools

pFMEAs

IQ / OQ / PQ / PPQ

TMVs

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.