Manufacturing Operator - First Shift

Cordis; Irvine (CA); On-site; USD 28,000 - 39,000; Full time

Job summary

Cordis in Irvine, CA is seeking an Operator I to join our medical device production team. You will operate equipment in a clean room, coat, inspect, and assemble components of balloon catheters and related products, while maintaining GMP and SOP adherence.

The role requires basic manufacturing experience, the ability to handle hazardous materials safely, and good documentation practices; English fluency is essential for communication and safety.

Qualifications

• High School diploma or equivalent is required.
• At least 12 months’ experience in a medical device or regulated manufacturing environment.
• Ability to use Microsoft Excel and other software.
• Ability to communicate ideas and issues to leads, supervisors, and management.
• Ability to work in a team and support overtime/weekend needs.
• Able to work with potentially hazardous chemicals and understand safety protocols.
• Fluent in English.

Responsibilities

• Operate machinery to produce medical devices per specifications.
• Update job documentation for traceability per instructions.
• Follow GMPs and good documentation practices.
• Set up, verify, and teardown equipment before/after processing.
• Prepare production materials and line clearance documents.
• Perform manufacturing tasks including fabrication, testing, packaging, and labeling.

Skills

Teamwork

Communication

Overtime flexibility

Reading procedures

Fluent English

Hazardous chemicals handling

Education

High School or equivalent

Tools

Microsoft Excel

Job description

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 I 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.

The Operator I ensures activities comply with GMPs, sets up coating machines, coats, inspects and folds balloon catheters, prepares excipient formulations and spray coating formulations, tests formulation, packages sterile and non-sterile finished good or semi-finished good, identifies supplies that need to be replenished, builds components needed for top level work orders, and performs 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

Required 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 $24.00 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

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.