Manufacturing Engineer Technician I - Med Device GMP

Cordis, LLC; Irvine (CA); On-site; USD 29,000 - 36,000; Full time

Job summary

Cordis LLC, in Irvine, is seeking a Manufacturing Engineer Technician I to support development and manufacture of drug-device products. You will help create robust processes, qualify tooling, and ensure GMP-compliant manufacturing and packaging of microsphere batches.

The role requires a HS diploma or GED, 2+ years in medical devices or pharma, and strong problem-solving, communication, and English fluency. Physical lifting up to 25 lbs is expected.

Qualifications

• HS diploma or GED required.
• 2+ years in medical device/pharma field or an associate’s degree with equivalent experience.
• Strong communication skills across levels of the organization.
• Detail-oriented with good organization and follow-up capabilities.
• Ability to make independent decisions.
• Familiarity with validation, verification, Gage R&R, FDA QSR and GMP.
• SolidWorks and CAD proficiency appreciated.
• Strong analytical, problem-solving and project management skills.
• Fluency in English.
• Ability to lift up to 25 lbs.

Responsibilities

• Assist development of manufacturing processes for existing products.
• Ensure transition from development to full-rate production with process stabilization.
• Develop and qualify new tooling and equipment.
• Validate processes, machines, and equipment (IQ/OQ/PQ).
• Troubleshoot issues and perform root-cause analysis with corrective actions.
• Manage hazardous waste handling per CAL-OSHA, EPA and regulations.
• Oversee fabrication schedules and optimize workflow with resource planning.
• Manage end-to-end inventory control and purchase orders.
• Perform in-process sampling, microscopic inspection, and particle testing.
• Oversee vialing and packaging of microsphere batches per GMP.

Skills

Communication

Organization

Attention to detail

Decision making

Analytical thinking

Project management

Problem solving

English fluency

Physical ability

Education

HS diploma or GED

Associate degree

Tools

SolidWorks

CAD

Job description

Cordis LLC, in Irvine, is seeking a Manufacturing Engineer Technician I to support development and manufacture of drug-device products. You will help create robust processes, qualify tooling, and ensure GMP-compliant manufacturing and packaging of microsphere batches.

The role requires a HS diploma or GED, 2+ years in medical devices or pharma, and strong problem-solving, communication, and English fluency. Physical lifting up to 25 lbs is expected.