Assembly Technician - Medical Devices

Position Summary Assemble medical instruments and their subassemblies following drawings and other written and verbal instructions, producing quality product per specifications. Perform other secondary operations as necessary. Essential Duties and Responsibilities Assemble components into medical devices using appropriate tooling and equipment, in accordance with approved manufacturing procedures and ISO & FDA regulations. Align components and assemble them together according to torque specifications. Load, operate and unload machine to break in cams. Perform assembly process functions including glue pads, paint, and Masterbond and Loctite assembly components. Troubleshoot and resolve work and assembly issues with the appropriate personnel as they arise. Perform in-process quality checks on sub-assemblies and finished product. Complete assigned jobs in accordance with production timelines. Maintain accurate records, certifications and documentation for order processing related to quality, work in progress, test results, etc. Maintain work flow, job packets, and routers through the assembly process as required. Responsible for maintaining appropriate product inventory levels. Perform preventative maintenance as needed. Maintain a clean and orderly work area. Meet and maintain established standards for scrap and indirect labor. Meet and maintain established production efficiency and effectiveness standards for running production. Proper and complete documentation of all production data in ERP system and required paperwork. Complete all documentation per ISO 13485 and FDA requirements. Cross train and perform additional operations specific to secondary operations to be a contributing member of a cross functional team. All other duties as assigned. Knowledge, Skills & Competencies 1-3 years of experience in mechanical assembly preferred. Experience in ISO/FDA environment preferred. Ability to read and interpret blueprints. Proficient in math, including the ability to add, subtract, multiply and divide. Excellent manual dexterity, hand/eye coordination and ability to work with very small components. Knowledge of raw materials, production processes, and quality control. Proficient in machine shop measuring equipment. Ability to be highly accurate with a high attention to detail. Possess strong mechanical aptitude. Ability to troubleshoot and problem solve assembly and other work issues. Ability to read and comprehend work instructions. Ability to repeat the same physical and mental activities over and over. Ability to maintain a sense of urgency, handle stressful situations, multitask and ability to prioritize work. Ability to work in a team environment as well as autonomously. Ability to communicate and interact effectively, professionally and constructively. Work Environment The noise level in the work environment is usually moderate. Includes exposure to sounds and noise levels that can be distracting or uncomfortable. Exposure to hand tools, presses and fixtures. Includes exposure to moving mechanical parts. Includes exposure to fumes or airborne particles, toxic or caustic chemicals. Work environment is temperature controlled. The work environment described here is representative of that which an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Requirements While performing the duties of this job the employee is regularly required to sit, stand or walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear. Ability to lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Ability to sit and stand for up to 12 hours per day. Requires repetitive movement. Requires bending and twisting. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Education, Certifications, and/or Licenses Requirements High school diploma or equivalent #J-18808-Ljbffr EXALTA Group