What are the responsibilities and job description for the Manufacturing Engineer (ISO 13485) position at Prismatik?
Essential Functions: Works alongside Materials Manufacturing team to learn and understand the equipment and processes in Material Manufacturing areas: BruxZir Colloidal, BruxZir Pressed, BruxZir Now, Composites, Resin, Obsidian, and Injection Molding.Provides engineering support by thoroughly understanding the functions of the various processes, products, and need of customers.Assists with troubleshoot and resolution of any issues or defects that may occur in the manufacturing process through application of hands-on skills and assessment of manufacturing machine program.Assesses process improvements under FDA design control and ISO 13485 change control guidelines.Understands lean manufacturing concepts and manufacturing flow to assist with definition, maintenance, and continuous improvement of process steps required to create customer products and processes.Assists with implementation of new and existing manufacturing process to improve safety, quality, and costs.Collaborates with team to analyze process data to evaluate effectiveness of manufacturing processes provides recommendation for improvements based on analysis.Assists with creation of work instructions, standard operating procedures (SOPs), and process related documents including but not limited to forms and certifications.Assists with generation of work packages including but not limited to detailed manufacturing instructions, drawings, bills of material (BOMs), references, and inspection requirements required to control production work.Assists with production request to avoid any delays in manufacturing.Analyzes and plans workflow, space requirements, and equipment layout to improve manufacturing efficiency.Collaborates with various departments to execute projects and tasks, including but not limited to Manufacturing, Engineering, R&D, Document Control, and RA/QA.Education and Experience: Bachelor of Science in Manufacturing, Mechanical, or Materials Engineering, or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved. Master’s degree a plus.Previous experience in medical device manufacturing, FDA design control and ISO 13485 knowledge preferred.Pay: $29.00 to $40.00/hr
Salary : $29 - $40
