Manufacturing Engineer III: Medical Device Innovation

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

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.