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Manufacturing Engineer I

2 months ago

Charlotte, United States Medical Murray Full time
Job DescriptionJob Description

Position Summary

The Manufacturing Engineering position performs equipment and process transfer from product development to production as well as improvements in equipment, tooling, and processes for ongoing production in the production department in support of the production department objectives to provide goods and services that meet customer’s requirements for quality quantity, and timeliness. The position will take on multiple projects of high complexity and provide mentoring, direction, and management on the day-to-day activities of the manufacturing engineering staff.


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

Skills, Knowledge and Abilities

  • Strength in problem-solving and decision making
  • High energy level, attention to detail, and a sense of urgency
  • Strong communication (written and verbal) and computer skills
  • Computer skills including MS Office, SolidWorks, or alternative CAD program
  • Knowledge of lean manufacturing techniques
  • Skills with statistics, preferably experience with DOEs, Minitab
  • Strong customer interaction skills

Experience

  • 0-3 years of experience with manufacturing and process engineering, medical device manufacturing preferred
  • ISO experience, cGMP and ISO 13485 preferred

Qualifications

  • Six Sigma Certificate preferred

Education

BS in Industrial or Mechanical Engineering preferred, or BS in Engineering required