Manufacturing Operator - First Shift

Cordis•Irvine, CA

11h•Onsite

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.

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

Responsibilities

Production of high-quality medical devices mostly in a clean room environment.
Formulation of polymers and spray coating formulations.
Production of a medical device using microscope and operation of various equipment and machines.
Ensuring activities comply with GMPs.
Setting up coating machines.
Coating, inspecting and folding balloon catheters.
Preparing excipient formulations and spray coating formulations.
Testing formulation.
Packaging sterile and non-sterile finished good or semi-finished good.
Identifying supplies that need to be replenished.
Building components needed for top level work orders.
Performing other duties as assigned.
Completing cleaning activities as required.
Operating machinery to produce medical devices according to specifications.
Following manufacturing instructions and accurately updating relevant job documentation for traceability.
Following good manufacturing practices and good documentation practices.
Performing setup, verification, and teardown of equipment before and after processing.
Preparing production materials and documents as part of line clearance.
Performing manufacturing tasks, including fabrication, in-process testing, and product packaging and labeling.
Documenting production activities in manufacturing lot history records.
Cleaning up production equipment and production area.
Performing analysis of data (as needed).
Troubleshooting product/process related issues.
Working with chemicals and powders in a lab environment.
Working in a clean environment wearing the proper PPE including wearing a respirator for long durations.
Executing the transfer, storage, and disposal of hazardous waste in strict compliance with CAL-OSHA, EPA, and Federal Hazardous Waste Regulations.
Having flexible working hours due to the nature of the microspheres production process.