Manufacturing Engineer III: Lean, Automation & GMP

BiVACOR; 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

Generous paid time off

Job summary

BiVACOR in Huntington Beach is developing the world's most advanced total artificial heart and seeks a Manufacturing Engineer III to optimize manufacturing processes. This critical role involves collaborating with engineering teams and ensuring regulatory compliance.

The ideal candidate has at least 5 years in engineering within the medical device industry, particularly with Lean and Six Sigma methodologies. Comprehensive benefits include medical insurance and a competitive salary of $120,000 to $127,000, with additional bonuses based on performance.

Qualifications

• 5+ years engineering experience preferably in the medical device industry.
• Expert in process characterization, pFMEAs, and quality standards.
• Working knowledge of industry best practices.

Responsibilities

• Design, develop, and improve manufacturing processes.
• Implement Lean and Six Sigma methodologies to optimize workflows.
• Conduct process validations and ensure compliance with regulatory standards.
• Analyze and resolve manufacturing issues.

Skills

Process development

Manufacturing Engineering

Six Sigma methodologies

Problem-solving

Education

BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering

MS desirable or equivalent

Tools

Lean manufacturing

FDA regulations

ISO 13485

Job description

BiVACOR in Huntington Beach is developing the world's most advanced total artificial heart and seeks a Manufacturing Engineer III to optimize manufacturing processes. This critical role involves collaborating with engineering teams and ensuring regulatory compliance.

The ideal candidate has at least 5 years in engineering within the medical device industry, particularly with Lean and Six Sigma methodologies. Comprehensive benefits include medical insurance and a competitive salary of $120,000 to $127,000, with additional bonuses based on performance.