New

Manufacturing Engineer Technician - Intermediate

Spectraforce Technologies
United States, California, Irvine
Jan 17, 2025
Job Title:- Manufacturing Engineer Technician Location:- Irvine, CA, 92602 Duration:- 10 months Shift:- 2:00 PM - 10:30 PM Role and Responsibilities:- 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 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 procedures and all applicable regulatory agency requirements. Other duties as assigned. Education:- Major/Field of Study Or Education Level Associates Degree In a technical field, electronics, or industrial mechanics. Experience/Background 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. CPRA: The Company is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.