Manufacturing Engineer

7 days ago

lake zurich, United States Brightpath Associates LLC Full time

Job Description

Position Summary:

The Manufacturing Engineer 2, Sustaining position performs engineering enhancements in production as well as improvements in equipment, tooling, and processes in the production department in support of the department objectives to provide goods and services that meet customer’s requirements for quality, quantity, and timeliness. The position will have a mixture of direct support of customers and sustaining engineering.

Essential Duties and Responsibilities:

  • Responsible to follow Medical Murray Quality system, including all applicable SOP's included in the Manufacturing Training Matrix
  • Perform process enhancements in production and implement process improvements utilizing Value Stream Mapping, 5S, and other relevant lean manufacturing tools
  • Support transfer of products into production after completion of transfer design review
  • Development of manufacturing processes for acceptable throughput and yield to achieve cost targets
  • Train assemblers on new or modified assembly procedures during production
  • Manage process validation following master validation plans after completion of transfer design review - including IQ, OQ, PQ, gauge R&R, and software validation
  • Support of capabilities studies and analysis of data during production
  • Coordination of design of custom equipment, fixtures, devices, and processes to meet customer requirements, improve quality and reduce cost of manufactured products
  • Acquisition, setup, and installation qualification of new equipment introduced to supported product lines
  • Support of equipment maintenance, as appropriate per skills and knowledge, manage escalation to Technology Manager. Support or perform equipment re-entry to production.
  • Engage and handoff activities to production.
  • Review of safety issues with equipment and processes and implementation of procedures and equipment modifications
  • Production line layout enhancements
  • Support annual risk analysis and manage DMR updates

Minimum Qualifications:

  • BS in Industrial, Biomedical or Mechanical Engineering or equivalent
  • 5 or more years of experience with sustaining and process engineering - contract manufacturing preferred
  • ISO experience, cGMP and ISO 13485 preferred
  • Six Sigma certificate preferred

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