Manufacturing Engineering Technician I (First Shift)

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

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 $21.95–$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.

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Job Locations US-CA-Irvine

ID 2026-13057

Category Manufacturing

Position Type Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]