Manufacturing Operator - First Shift

Cordis•Irvine, CA

7d•$24

About The Position

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. 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.

Requirements

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.
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).
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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.