Manufacturing Engineering Technician I (Second Shift)

Cordis; Irvine (CA); On-site; USD 30,000 - 38,000; Full time

Job summary

Cordis in Irvine is seeking a Manufacturing Engineer Technician I (Second Shift) to support the development and manufacturing of drug-device products. You will help build robust processes, transfer tech from development to production, and ensure quality and GMP-compliant operations.

The role requires 2+ years in medical device/pharma, a HS diploma, English fluency, and ability to lift 25 lbs. This on-site position offers growth in a collaborative environment.

Qualifications

• HS diploma or GED.
• 2+ years in medical device or pharmaceutical field or equivalent.
• Strong verbal and written communication skills.
• Excellent organization and follow-up with attention to detail.
• Ability to make independent decisions.
• Knowledge of validation/verification, Gage R&R, FDA QSR and GMP.
• SolidWorks CAD knowledge is a plus.
• Fluent in English.

Responsibilities

• Assist in developing manufacturing processes for existing products.
• Incorporate robust transition from development to full-rate production; stabilize processes.
• Develop and qualify new tooling and equipment.
• Verify and validate processes, machines per procedures (IQ/OQ/PQ).
• Troubleshoot issues and implement corrective/preventive actions.
• Manage hazardous waste handling per CAL-OSHA/EPA regulations.
• Oversee fabrication schedules and optimize workflow within resources.
• Manage end-to-end inventory and safety stock for fabrication components.
• Perform in-process sampling, inspection, and particle testing.
• Maintain GMP-compliant processing and packaging of microsphere batches.

Skills

Verbal and written communication

Organization and follow-up

Independent decision-making

Analytical/problem-solving

Project management

Fluent in English

FDA QSR & GMP knowledge

Problem solving

Education

HS diploma or GED

Associate's degree or equivalent

Tools

SolidWorks

CAD software

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

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

Pay / Compensation

The expected pre-tax pay rate for this position is $21.95–$27.50 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.