Senior Manufacturing Engineer - Medical Device

BiVACOR Inc; 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

Generous paid time off

Job summary

BiVACOR Inc is seeking a Manufacturing Engineer IV in Huntington Beach, California, to drive the development of cutting-edge manufacturing processes for total artificial hearts. The role demands advanced technical leadership, driving efficiency and quality while adhering to regulatory standards.

The ideal candidate has over 8 years of engineering experience, preferably in the medical device sector, and will oversee significant projects, mentor engineers, and ensure compliance with FDA and ISO standards.

Qualifications

• 8+ years of engineering experience in manufacturing or medical device industry.
• Deep expertise in process characterization and validation programs.
• Comprehensive knowledge of medical device quality regulations.

Responsibilities

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

Skills

Process development

Manufacturing Engineering

Validation programs

Problem-solving

Cross-functional project management

Lean and Six Sigma methodologies

Education

BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering

MS desirable or equivalent experience

Tools

ISO 13485

FDA quality system regulations

Project management tools

Job description

BiVACOR Inc is seeking a Manufacturing Engineer IV in Huntington Beach, California, to drive the development of cutting-edge manufacturing processes for total artificial hearts. The role demands advanced technical leadership, driving efficiency and quality while adhering to regulatory standards.

The ideal candidate has over 8 years of engineering experience, preferably in the medical device sector, and will oversee significant projects, mentor engineers, and ensure compliance with FDA and ISO standards.