Manufacturing Engineer II - Polymer/Resin

Manufacturing (Prismatik, a Glidewell company) Irvine, California


Description

Position at Prismatik

Essential Functions: 
  • Provides engineering support for new and ongoing operations related to Materials Manufacturing, with a focus on polymer-based materials and/or resin manufacturing processes.
  • Troubleshoots manufacturing issues, improves operations in an FDA regulated and ISO 13485 certified environment, and researches, develops, and implements manufacturing techniques as part of a team effort to drive continuous improvement.
  • Designs and develops manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
  • Interprets and validates manufacturing processes and documentation in accordance with required specifications.
  • Troubleshoots and resolves any issues or defects that may occur in the manufacturing process through application of hands-on skills and assessment of manufacturing machine program.
  • Effectively applies lean manufacturing concepts and manufacturing flow to define, maintain, and continuously improve process steps required to create customer products and processes.
  • Enhances current manufacturing processes improvements under FDA design control and ISO 13485 change control guidelines.
  • 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 including but not limited to Manufacturing, Engineering, R&D, Document Control and RA/QA.
  • Performs other related duties and projects as business needs require at the direction of management.
Minimum Qualifications: 
  • Bachelor of Science in Manufacturing, Mechanical, Materials, or Polymer Engineering (or related field), or equivalent experience. Master’s degree a plus.
  • Minimum two (2) years of related work experience in Manufacturing.
  • Experience with polymer engineering, resin manufacturing, and/or additive manufacturing (e.g., 3D printing resins) strongly preferred.
  • Previous experience in medical device manufacturing, FDA design control and ISO 13485 knowledge.
  • Applied mechanical skills to apply engineering concepts and mechanical processes to the design of new devices and systems.
  • Lean Manufacturing certification preferred.
  • Ability to frequently push and/or pull up to twenty-five (25) pounds.
  • Ability to frequently lift or carry up to twenty-five (25) pounds.
Pay range: $36.40-$50.00/hr
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.

Glidewell is an equal opportunity employer, including disability and veteran status.

Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.