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Manufacturing Engineer 1

Manufacturing Engineer 1

Cook GroupEllettsville, IN, US
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Overview

The Manufacturing Engineer 1 is responsible for providing technical support for the day-today production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices.

Responsibilities

  • Provides process support for extrusion department
  • Hands-on position with visibility on the manufacturing floor
  • Requires a high level of interaction with the production, product development, and quality teams
  • Supports product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives
  • Supports production departments' manufacturing issues with technical support as the process expert. Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence
  • Supports and drives continuous improvement activities in the manufacturing department to improve operational performance. Leads technical aspect of process validation projects
  • Assist product development teams with design for manufacturability requirements on new products. Supports new capital equipment and tooling purchases with appropriate documentation and evaluation
  • Manages multiple technically oriented projects through coordinating internal and external resources
  • Collaborates on product complaint resolution

Qualifications

  • High School Diploma with applicable experience is required; Bachelor's degree in Engineering / Plastics Engineering preferred
  • 3+ years of extrusion process development experience
  • 5+ years of work related to polymer processing preferred
  • Process validation (IQ, OQ, PQ) preferred
  • Equipment qualification (IQ, OQ, PQ) preferred
  • Fundamental understanding engineering principles
  • Extrusion process development / Extrusion Tooling Design
  • Mechanical aptitude preferred
  • Understanding of ISO 13485 : 2016 preferred
  • CFR, FDA, OSHA, environmental regulations preferred
  • Proficiency at using Microsoft Office applications
  • Troubleshooting and problem-solving skills
  • Equipment / process troubleshooting preferred
  • Experience with blue print reading preferred
  • Design of Experiments / Six Sigma preferred

    • Physical Requirements :

  • May exert up to 20 pounds of force frequently, and / or a negligible amount of force constantly to move objects

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    Manufacturing Engineer • Ellettsville, IN, US

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