Manufacturing Engineer III - Lean Process & CAPA Leader

Bio-Rad Laboratories; Irvine (CA); On-site; USD 121,000 - 167,000; Full time

Benefits offered by this job

Competitive medical plans

401k with profit sharing

Employee stock purchase program

Paid parental leave

Job summary

Bio-Rad Laboratories in Irvine, CA is seeking a Manufacturing Engineer III to lead the design, development, and optimization of manufacturing processes for medical devices. You will drive continuous improvement, ensure regulatory compliance, and support manufacturing transfers and CAPA activities.

The role requires a Bachelor’s or Master’s in engineering, 7+ years of industry experience (medical device manufacturing preferred), and strong problem-solving and documentation skills.

Qualifications

• Bachelor’s or Master’s degree in engineering or scientific field required.
• 7+ years of industry experience, preferably in medical device manufacturing.
• Strong documentation skills and understanding of GDP/regulatory requirements.

Responsibilities

• Lead design, development, and optimization of manufacturing processes.
• Drive continuous improvement to increase capacity and reduce costs.
• Support QMS, CAPA, change management, and transfers.
• Collaborate with suppliers and internal teams to qualify equipment.

Skills

Lean manufacturing

Problem solving

Documentation

Education

Bachelor’s or Master’s degree in engineering/scientific field

Tools

SAP

Job description

Bio-Rad Laboratories in Irvine, CA is seeking a Manufacturing Engineer III to lead the design, development, and optimization of manufacturing processes for medical devices. You will drive continuous improvement, ensure regulatory compliance, and support manufacturing transfers and CAPA activities.

The role requires a Bachelor’s or Master’s in engineering, 7+ years of industry experience (medical device manufacturing preferred), and strong problem-solving and documentation skills.