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Cordis · 2 months ago

Manufacturing Engineering Technician II (Second Shift)

Irvine, CA

Full-time

Onsite

Entry, Mid Level

$23.27/hr - $29.09/hr

2+ years exp

Cordis, in partnership with Selution, specializes in the development of advanced drug device combination products for healthcare. The Manufacturing Engineering Technician II will aid in developing and optimizing manufacturing processes, ensuring product transition to full production, and maintaining compliance with quality standards.

Health CareHealth DiagnosticsMedical

No H1B

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

Qualification

Validation verification processFDA's QSRGMPSolidWorksAnalytical skillsProject managementIndependent decision makingFluent in EnglishCommunication skillsOrganizational skillsProblem solvingAttention to detail

Required

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa

HS diploma or GED

2+ years related work experience in the medical device or pharmaceutical field, or associate's degree and equivalent work experience

Strong verbal and written communication skills with 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 validation verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP

Basic proficiency in SolidWorks and computer-aided design a plus

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

You must be able to lift and carry up to 25 lbs