Manufacturing Engineering Technician I (Second Shift)

Cordis•Irvine, CA

8d•Onsite

About The Position

Selution, in partnership with Cordis, specializes in the development of groundbreaking 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.

Requirements

HS diploma or GED
2+ years of related work experience in the medical device or pharmaceutical field, or an associate's degree and equivalent work experience.
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization
Strong organization and follow-up skills, as well as attention to detail
Ability to make independent decisions
Knowledge of the validation verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP
Strong analytical, problem-solving, and project management skills
Fluent in English
Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA, and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards

Nice To Haves

Basic proficiency in SolidWorks and computer-aided design a plus

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 and 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.