Senior Manufacturing Engineer, Medical Devices & Automation

BiVACOR; Huntington Beach (CA); On-site; USD 130,000 - 153,000; Full time

Benefits offered by this job

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

Job summary

BiVACOR, based in Huntington Beach, California, is seeking a Manufacturing Engineer IV. This role leads the design and improvement of manufacturing processes for the Total Artificial Heart, aiming for high quality and efficiency.

With at least 8 years of experience in engineering and a background in medical device regulations, you will also mentor junior engineers and manage cross-functional projects. The position offers a competitive salary and comprehensive benefits, including a 401(k) plan and health insurance.

Qualifications

• 8+ years of engineering experience with advanced skills in process development and industrialization.
• Deep expertise in medical device quality regulations including ISO 13485 and FDA.
• Experience leading cross-functional engineering projects and mentoring junior engineers.

Responsibilities

• Lead the design, development, and improvement of manufacturing processes.
• Champion Lean and Six Sigma methodologies for waste reduction.
• Manage complex cross-functional manufacturing engineering projects.

Skills

Process development

Manufacturing Engineering

Lean methodologies

Six Sigma

Technical leadership

Education

BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering

MS desirable

Tools

pFMEAs

IQ/OQ/PQ/PPQ

TMVs

Job description

BiVACOR, based in Huntington Beach, California, is seeking a Manufacturing Engineer IV. This role leads the design and improvement of manufacturing processes for the Total Artificial Heart, aiming for high quality and efficiency.

With at least 8 years of experience in engineering and a background in medical device regulations, you will also mentor junior engineers and manage cross-functional projects. The position offers a competitive salary and comprehensive benefits, including a 401(k) plan and health insurance.