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.

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.    

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.