Our Client, a Medical Device And Healthcare Company, is looking for Manufacturing Engineer Technician – Intermediate for their Irvine, CA location Responsibilities + Responsible for performing functions associated with all manufacturing operations, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies, and final assemblies. + Determines and may assist in developing methods and procedures to control or modify the manufacturing process. + Works with engineers in conducting experiments. + Observes and complies with all safety rules and regulations. + This includes QSR and ISO Standards. + Participates in the Material Review Board (MRB) decision process. + Identifies and implements corrective actions for manufacturing related issues. + Performs equipment setup and corrective, preventive and calibration maintenance, as necessary. + Installs and validates equipment’s and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure. + Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. + May develop or revise documents and procedures. + Certifies manufacturing associates in the production processes. + Evaluates and orders necessary equipment, tools and fixtures. + In collaboration with engineering and maintenance departments, provides technical support to production and engineering by monitoring, assessing, testing, and recalibration machinery, equipment and processes. + The technician will work closely with engineering to implement improvements on the line, develop and build fixturing, qualify equipment, and troubleshoot failures. + Performs set-up, maintenance and coordinates calibration activities of production equipment to ensure uninterrupted, optimum manufacturing conditions. + Troubleshoots and make necessary repairs to equipment using problem solving methods as root cause analysis. + Requires work in controlled access environment and adherence to medical device manufacturing standards and regulations. + Supports product transfer and continuous improvement projects by providing, installation, set-up, generate maintenance and calibration procedures, and execute equipment, process, and product validations. + Gathers information on current production equipment and systems to determine causes of inefficiencies or errors. Identifies and implements continuous improvement opportunities to minimize or eliminate errors to ensure production equipment and systems operates uninterruptible and in optimum conditions. + Performs maintenance work orders to production equipment and systems by the assigned dues dates. + Performs and documents all mechanical and or electrical troubleshooting of product as required following all applicable Client procedures. + Gathers information on current production equipment, tooling and systems to determine proper spare stock. + Coordinates purchasing and storage of necessary spare parts, tools and fixtures to ensure production equipment and systems operates uninterruptible and in optimum conditions. + Ensure compliance with all Client procedures and all applicable regulatory agency requirements. + Other duties as assigned. Requirements + Associates Degree In a technical field, electronics, or industrial mechanics. + Three (3) to five (5) years of experience in a regulated industry. + Knowledge of FDA, GMP and ISO guidelines is preferred. + Experience with equipment troubleshooting, and electrical knowledge. + Experience with troubleshooting non-conforming or rejected product is beneficial. + Flexible and adaptable due to rapid changes in product demand and project priority, team player, self-starter, keen to acquire new skills. + Fluency of English (written and speaking) is required. + This position supports a 2nd shift production ramp for a medical device manufacturing line, and provide engineering support on improvements that will impact both 1st and 2nd shift. + H.S. diploma or equivalent plus 3-5 years of related work experience or equivalent combination. + Two-year degree or some college credits preferred. Why Should You Apply? + Health Benefits + Referral Program + Excellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.