Manufacturing Technician

MAJOR DUTIES AND RESPONSIBILITIESResponsibilities will include, but not be limited to:Manufacture commercial, prototype, pre-clinical and clinical units in a Cleanroom Environment. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packagingOperate computer-controlled machineryComplete manufacturing documentation such as Lot History Records (LHR) in compliance with Good Documentation Practices (GDP)Perform preventive maintenance as required for production equipmentOrganize and assemble materials and product shipments to support commercial and development programsInspect/test components and assemblies as part of in-process inspection Maintain work area cleanliness and compliance with various safety, fire, and hazmat guidelinesExecute work in a manner compliant with FDA and ISO guidelines for medical device development and manufactureMaintain compliance with all document and procedure training requirementsQUALIFICATIONSExperience High School diplomaMinimum two years experience as a technician in the medical device industry in a Cleanroom EnvironmentExperience with manufacture and mechanical testing of product Experience with GDP-compliant manufacturing documentation Ability to follow established written procedures with minimum supervisionGood oral communication skillsBasic computer skills Ability to lift, move and carry up to 10 lbs.

Created: 2025-04-27