Manufacturing Engineering Technician II

Cordis • Irvine, CA

71d

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

• Assist in the development of highly capable manufacturing processes for existing products in manufacturing
• Ensure robust transition from product development through full rate production ensuring process stabilization
• Develop, and qualify new tooling and equipment
• Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols
• Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans
• Help execute the transfer, storage, and disposal of hazardous waste in strict compliance with CAL-OSHA, EPA, and Federal Hazardous Waste Regulations
• Assist in developing and overseeing detailed fabrication schedules for manufacturing runs, optimizing workflow efficiency while balancing resource availability and operational timelines
• Help manage end-to-end inventory control, including purchase order requests, while maintaining safety stock levels and contingency supplies for all fabrication module components, including specialized tools and chemical excipients
• Perform in-process sampling, microscopic visual inspection, and particle analytical testing to ensure adherence to rigorous manufacturing and safety standards
• Maintain compliance and execute the processing and packaging (vialing) of both internal and external microsphere batches, ensuring compliance with GMP and Cordis quality requirements.

What This Job Offers

• Number of Employees: 1,001-5,000 employees