Manufacturing Operator - First Shift

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.

• 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.