Manufacturing Engineer (Monday to Friday 8:00am to 4:30pm)

PrismatikIrvine, CA
$34 - $37Onsite

About The Position

This role provides engineering support to the Materials Manufacturing team, focusing on understanding and improving equipment and processes across various manufacturing areas including BruxZir Colloidal, BruxZir Pressed, BruxZir Now, Composites, Resin, Obsidian, and Injection Molding. The engineer will troubleshoot manufacturing issues, assess process improvements under regulatory guidelines, and contribute to lean manufacturing initiatives. This position involves collaborating with multiple departments to implement new processes, analyze data for effectiveness, and create essential manufacturing documentation.

Requirements

  • Bachelor of Science in Manufacturing, Mechanical, or Materials Engineering, or any equivalent education and/or experience.
  • Demonstrated knowledge, skills, and abilities comparable to a Bachelor's degree in a relevant engineering field.

Nice To Haves

  • Master’s degree
  • Previous experience in medical device manufacturing

Responsibilities

  • Learn and understand the equipment and processes in Material Manufacturing areas.
  • Provide engineering support by understanding functions of processes, products, and customer needs.
  • Assist with troubleshooting and resolution of manufacturing issues or defects.
  • Assess process improvements under FDA design control and ISO 13485 change control guidelines.
  • Understand lean manufacturing concepts and manufacturing flow to assist with definition, maintenance, and continuous improvement of process steps.
  • Assist with implementation of new and existing manufacturing processes to improve safety, quality, and costs.
  • Collaborate with the team to analyze process data and evaluate manufacturing process effectiveness.
  • Assist with creation of work instructions, standard operating procedures (SOPs), and process-related documents.
  • Assist with generation of work packages including detailed manufacturing instructions, drawings, bills of material (BOMs), references, and inspection requirements.
  • Assist with production requests to avoid manufacturing delays.
  • Analyze and plan workflow, space requirements, and equipment layout to improve manufacturing efficiency.
  • Collaborate with various departments to execute projects and tasks.
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