Assembly Technician (Cleanroom) - 1st, 2nd, & 3rd Shift Openings
Overview
Assembly Technician needs to be self-sufficient in assembly, testing and documentation of mechanical and electrical assemblies.
Duties & Responsibilities:
* Maintain Clean Room integrity by using proper attire and adherence to Clean Room environment practices and procedures as applicable.
* Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures.
* Utilize small hand tools (both manual and electric), manual presses, assembly fixtures, calibrated instruments, measurement equipment, microscopes, and test fixtures.
* Utilize documentation such as Bill of Materials, product flow charts, work orders, check sheets, visual aids, production reports and assembly drawings to assemble product and record results.
* May perform soldering, fabricating, crimping, mechanical assembly, sealing, ultra-sonic welding, bonding and gluing with adhesives, Epoxy or RTV.
* Kitting assemblies using a parts list, scanner and inventory software as required.
* Participate in continuous improvement activities as part of a cross-functional team.
* Meet all quality, quantity and good manufacturing practices to satisfy customer and Regulatory Affairs requirements.
* Read and/or understand operating procedures for specific products where training has been completed.
* Work with Engineers and line leads to resolve issues and correct procedures to ensure quality and efficiency.
* Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards), and special projects.
* Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO, QSR, and FDA regulations.
Qualifications
* Minimum of 1 year hands-on experience in a manufacturing environment.
* Experience with assembly, testing and the documentation of mechanical and electrical devices.
* Exceptional interpersonal, verbal, and written communication skills are required.
* Willingness to undertake various tasks and adapt to unexpected situations within dynamic company environment.
* Medical device manufacturing experience.
* Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes.
* Good hand eye coordination and manual dexterity required.
* Small parts assembly and able to work under a microscope.
* Utilize tweezers, torque drivers, magnifiers and microscopes.
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