Manufacturing Engineer III

The role

The Manufacturing Engineer III develops, optimizes, and implements manufacturing processes for the BiVACOR total artificial heart. This role focuses on integrating value engineering principles and ensuring high-quality, cost-effective manufacturing for implantable components.

What you will do

• Design, develop, and improve manufacturing processes.
• Implement Lean and Six Sigma methodologies.
• Implement automation and advanced manufacturing techniques.
• Design, procure, and validate equipment, tools, and fixtures.
• Ensure proper calibration and maintenance of manufacturing equipment.
• Conduct process validations (IQ, OQ, PQ).
• Ensure compliance with FDA, ISO 13485, and GMP standards.
• Support NC/CAPA investigations and implement corrective actions.
• Create and maintain manufacturing documentation.
• Prepare technical reports for audits and regulatory submissions.

Required qualifications

• BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering (or equivalent)
• 5+ years engineering experience including skills in process development, Manufacturing Engineering and industrialization
• Expert in process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs.
• 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)

Nice to have

• MS desirable
• preferably in the medical device industry or other highly regulated industry

Benefits

• 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

About the company

BiVACOR is developing the world's most advanced total artificial heart. The company is an equal opportunity employer.