Manufacturing Operator II (United States)

Cordis • Irvine, CA • 3h ago

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking 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

The Operator II is responsible for the production of high-quality medical devices mostly in a clean room environment. This position includes formulation of polymers and spray coating formulations, production of a medical device using microscope and operation of various equipment and machines.

Responsibilities ?

The Operator II ensures activities comply with GMPs, set up coating machines, coat, inspect and fold balloon catheters, prepare excipient formulations and spray coating formulations, test formulation, package sterile and non-sterile finished good or semi-finished good, identify supplies that need to be replenished, build components needed for top level Work Orders, other duties as assigned. Complete cleaning activities as required.

Operating machinery to produce medical devices according to specifications.?

Following manufacturing instructions and accurately updating relevant job documentation for traceability

Must follow good manufacturing practices and good documentation practices.?

Perform setup, verification, and teardown of equipment before and after processing.?

Prepare production materials and documents as part of line clearance.?

Perform manufacturing tasks, including fabrication, in-process testing, and product packaging and labeling.?

Document production activities in manufacturing lot history records.?

Clean up production equipment and production area.?

Perform analysis of data (as needed).

Troubleshoot product/process related issues.

Work with chemicals and powders in a lab environment.

Must be able to work in a clean environment wearing the proper PPE including wearing a respirator for long durations.?

Help execute the transfer, storage, and disposal of hazardous waste in strict compliance with CAL-OSHA, EPA, and Federal Hazardous Waste Regulations.

Have flexible working hours due to the nature of the microspheres production process.

Other duties as assigned.???

Qualifications

Qualifications ?

High School or equivalent education.?

Minimum 12 months' experience in a medical device or other regulated manufacturing industry.?

Ability to utilize Microsoft Excel and other relevant computer software.

Ability to be able to communicate ideas, problems and solutions to manufacturing lead, supervisor and management.?

Ability to work in a team environment.?

Ability to work overtime and/or weekends, according to business needs.?

Ability to work with potentially hazardous chemicals.?

Ability to read, comprehend, and follow written procedures. Understand and follow verbal instructions.?

Fluent in English.??

Physical Requirements

Requires walking, lifting a maximum of 10 to 15lbs, lifting above head, bending, twisting, pushing, stretching, squatting, pulling, reaching, standing, climbing, and carrying.?

Position requires standing for an extended period of time.?

Dexterity and physical condition to perform some level of repetitive motion tasks and maintain pace of a continuous production process.?

Adequate eyesight to ensure effective inspection of product, labeling and packaging. (Use of corrective lenses acceptable).?

Pay / Compensation

The expected pre-tax pay rate for this position is $26.00 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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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 teammate-s 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 2025-12061

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 GlobalHR@Cordis.com

Cordis

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