Manufacturing Operator - Second Shift

Cordis; Irvine (CA); On-site; USD 27,000 - 39,000; Full time

Job summary

Cordis in Irvine, CA is seeking a Manufacturing Operator I (Second Shift) to produce high-quality medical devices in a clean room environment. The role includes polymer formulations, spray coatings, and balloon catheter assembly, while maintaining GMP/compliant documentation.

Responsibilities cover setting up and operating coating equipment, inspecting finished goods, line clearance, packaging, and data recording. Candidates should be able to work overtime and wear PPE as required.

Qualifications

• High School or equivalent education required.
• Experience in medical device or regulated manufacturing preferred.
• Ability to read procedures and follow instructions.

Responsibilities

• Operate machinery to produce medical devices following specs.
• Update job documentation for traceability and GMP compliance.
• Setup, verify, and teardown equipment; prepare materials for line clearance.
• Perform packaging, labeling, in-process testing and cleaning.
• Document production activities and maintain cleanroom standards.

Skills

Second shift

Team environment

Excel / software

Communicate with manufacturing lead

Overtime/weekends

Education

High School or equivalent

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 Manufacturing Operator I (Second Shift) 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.

Responsibilities

• 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

• Ability to work second shift hours
• 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.