Manufacturing Operator - Second Shift

Manufacturing Operator I (Second 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 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.
• 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:

• 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.