Manufacturing Engineering Technician I (First Shift)

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

Job summary

Cordis is seeking a Manufacturing Engineer Technician I in Irvine, CA to support development and transition of manufacturing processes for drug-device products. The role emphasizes tooling qualification, process validation, and strict compliance with GMP and safety standards.

You will perform in-process sampling, inspection, and packaging, while coordinating with cross-functional teams to maintain efficient production schedules and inventory control.

Qualifications

• HS diploma or GED required.
• 2+ years in medical device/pharma field or equivalent.
• Strong communication, organization and attention to detail.
• Ability to make independent decisions and work cross-functionally.
• Familiarity with validation/verification, Gage R&R, FDA QSR and GMP.

Responsibilities

• Assist in developing manufacturing processes and ensure smooth transition to full-rate production.
• Develop and qualify new tooling and equipment.
• Verify and validate processes, IQ/OQ/PQ protocols.
• Troubleshoot issues and perform root cause analysis with corrective actions.
• Handle hazardous waste in compliance with CAL-OSHA, EPA and regulations.
• Create fabrication schedules and optimize workflow while balancing resources.
• Manage end-to-end inventory and purchase orders with safety stock.
• Perform in-process sampling and visual/particle inspections.
• Ensure GMP compliance and packaging of microsphere batches.

Skills

Communication skills

Organization

Independent decision making

Analytical problem solving

Project management

English fluency

Lifting up to 25 lbs

Validation & GMP knowledge

Gage R&R

SolidWorks

Education

HS diploma or GED

Tools

SolidWorks

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.

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.

Preferred Qualifications

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.