Manufacturing Engineering Technician I (First Shift)

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

Job summary

Cordis LLC, in Irvine, is seeking a Manufacturing Engineer Technician I to support development and manufacture of drug-device products. You will help create robust processes, qualify tooling, and ensure GMP-compliant manufacturing and packaging of microsphere batches.

The role requires a HS diploma or GED, 2+ years in medical devices or pharma, and strong problem-solving, communication, and English fluency. Physical lifting up to 25 lbs is expected.

Qualifications

• HS diploma or GED required.
• 2+ years in medical device/pharma field or an associate’s degree with equivalent experience.
• Strong communication skills across levels of the organization.
• Detail-oriented with good organization and follow-up capabilities.
• Ability to make independent decisions.
• Familiarity with validation, verification, Gage R&R, FDA QSR and GMP.
• SolidWorks and CAD proficiency appreciated.
• Strong analytical, problem-solving and project management skills.
• Fluency in English.
• Ability to lift up to 25 lbs.

Responsibilities

• Assist development of manufacturing processes for existing products.
• Ensure transition from development to full-rate production with process stabilization.
• Develop and qualify new tooling and equipment.
• Validate processes, machines, and equipment (IQ/OQ/PQ).
• Troubleshoot issues and perform root-cause analysis with corrective actions.
• Manage hazardous waste handling per CAL-OSHA, EPA and regulations.
• Oversee fabrication schedules and optimize workflow with resource planning.
• Manage end-to-end inventory control and purchase orders.
• Perform in-process sampling, microscopic inspection, and particle testing.
• Oversee vialing and packaging of microsphere batches per GMP.

Skills

Communication

Organization

Attention to detail

Decision making

Analytical thinking

Project management

Problem solving

English fluency

Physical ability

Education

HS diploma or GED

Associate degree

Tools

SolidWorks

CAD

Job description

Overview

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.

Responsibilities

As a Manufacturing Engineer Technician I,your responsibilities include:

• 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.

Qualifications

• 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.

Pay / Compensation

The expected pre-tax pay rate for this position is $21.15 – $26.44 per hour. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

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