Manufacturing Engineer III

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
• Design, procure, and validate equipment, tools, and fixtures
• 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
• Analyze and resolve manufacturing issues and non-conformances
• Provide technical support to production teams and train operators

Requirements

• BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering
• 5+ years of engineering experience in process development and industrialization
• Experience in medical device or highly regulated industries
• Expertise in process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs
• Working knowledge of ISO 13485 and FDA quality system regulations
• Advanced problem-solving skills (Six Sigma Green or Black Belt)

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, a technology capable of saving millions of lives around the world.