Manufacturing Engineer Tech I — Shape Medical Devices

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

Job summary

Cordis is seeking a Manufacturing Engineer Technician I in Irvine, CA to support development and transition of manufacturing processes for drug-device products. The role emphasizes tooling qualification, process validation, and strict compliance with GMP and safety standards.

You will perform in-process sampling, inspection, and packaging, while coordinating with cross-functional teams to maintain efficient production schedules and inventory control.

Qualifications

• HS diploma or GED required.
• 2+ years in medical device/pharma field or equivalent.
• Strong communication, organization and attention to detail.
• Ability to make independent decisions and work cross-functionally.
• Familiarity with validation/verification, Gage R&R, FDA QSR and GMP.

Responsibilities

• Assist in developing manufacturing processes and ensure smooth transition to full-rate production.
• Develop and qualify new tooling and equipment.
• Verify and validate processes, IQ/OQ/PQ protocols.
• Troubleshoot issues and perform root cause analysis with corrective actions.
• Handle hazardous waste in compliance with CAL-OSHA, EPA and regulations.
• Create fabrication schedules and optimize workflow while balancing resources.
• Manage end-to-end inventory and purchase orders with safety stock.
• Perform in-process sampling and visual/particle inspections.
• Ensure GMP compliance and packaging of microsphere batches.

Skills

Communication skills

Organization

Independent decision making

Analytical problem solving

Project management

English fluency

Lifting up to 25 lbs

Validation & GMP knowledge

Gage R&R

SolidWorks

Education

HS diploma or GED

Tools

SolidWorks

Job description

Cordis is seeking a Manufacturing Engineer Technician I in Irvine, CA to support development and transition of manufacturing processes for drug-device products. The role emphasizes tooling qualification, process validation, and strict compliance with GMP and safety standards.

You will perform in-process sampling, inspection, and packaging, while coordinating with cross-functional teams to maintain efficient production schedules and inventory control.