Manufacturing Tech I - Medical Devices (2nd Shift)

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

Job summary

Cordis, LLC is seeking a Manufacturing Engineer Technician I (Second Shift) to support scalable production of medical devices in Irvine, CA. You will help transition products from development to full-rate production while maintaining process stability.

The role requires hands-on manufacturing process development, tooling qualification, IQ/OQ/PQ, and problem-solving to prevent issues. You will work with cross-functional teams and ensure compliance with GMP and safety standards.

Qualifications

• HS diploma or GED required.
• 2+ years of related work experience in medical device or pharmaceutical field, or an associate's degree and equivalent experience.
• Strong verbal and written communication skills across organizational levels.
• Attention to detail and strong organizational abilities.
• Ability to make independent decisions.
• Knowledge of validation/verification process, Gage R&R, FDA QSR and GMP.
• Proficiency in SolidWorks and CAD is a plus.
• Strong analytical, problem-solving, and project management skills.
• Fluent in English.
• Ability to lift up to 25 lbs.

Responsibilities

• Assist in developing manufacturing processes for existing products.
• Ensure smooth transition from development to full-rate production with stabilized processes.
• Develop and qualify new tooling and equipment.
• Perform IQ/OQ/PQ verifications and validations per procedures.
• Troubleshoot issues and perform root-cause analysis with corrective actions.
• Assist in handling hazardous waste disposal per CAL-OSHA, EPA regulations.
• Develop detailed fabrication schedules to optimize workflow and timelines.
• Manage end-to-end inventory including POs and safety stock.
• Perform in-process sampling, inspection, and particle testing for quality.
• Package and vial internal and external microsphere batches per GMP requirements.

Skills

Communication

Organization

Decision making

Validation knowledge

Gage R&R

SolidWorks

CAD

Analytical skills

English fluency

Lifting 25 lbs

Education

High school diploma

Associate degree

Tools

SolidWorks

CAD

Job description

Cordis, LLC is seeking a Manufacturing Engineer Technician I (Second Shift) to support scalable production of medical devices in Irvine, CA. You will help transition products from development to full-rate production while maintaining process stability.

The role requires hands-on manufacturing process development, tooling qualification, IQ/OQ/PQ, and problem-solving to prevent issues. You will work with cross-functional teams and ensure compliance with GMP and safety standards.