Manufacturing Engineering Technician I (Second 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

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 (Second Shift), 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 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.

Qualifications

• 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
• 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.