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Senior Manufacturing Engineer

1 month ago

Hillsboro, United States Marmon Holdings, Inc. Full time

Job Title: Senior Manufacturing Engineer

Job Summary:

The Senior Manufacturing Engineer is a key member of our team at Marmon Holdings, Inc. responsible for supporting the life cycle of Acumed medical devices by meeting operational objectives in production. This includes developing, integrating, validating and improving production processes and systems.

Key Responsibilities:

  • Develop and implement production processes and systems
  • Own continuous improvement of existing processes through the elimination of waste and/or the adoption of new methods of manufacturing
  • Support our quality-first culture by ensuring all processes are aligned to regulated Good Manufacturing Practices (GMPs)
  • Provide manufacturing engineering expertise through detailed process characterization, process documentation, equipment selection, fixture design, and testing
  • Manage corrective/preventative actions (CAPA)
  • Use appropriate statistical techniques to develop validation protocols and complete process capability studies
  • Lead continuous improvement initiatives and implement Lean tools
  • Write and execute Process Validation protocols and reports
  • Perform root cause investigations on product non-conformances
  • Prepare new equipment proposals including ROI justification
  • Establish calibration and preventative maintenance specifications
  • Manage technical and complex projects and lead cross-functional groups
  • Communicate effectively with all levels of the organization

Requirements:

  • B.S. Degree in Engineering (Chemical, Mechanical, Manufacturing, Industrial) or equivalent
  • 5+ years manufacturing engineering or related experience
  • Experience with Process Validation (IQ, OQ, and PQ)
  • Experience with selection and commissioning of new production equipment
  • Experience with ROI financial analysis and investment justification
  • Experience with statistical tools such as control charts, trending, and capability with Minitab or equivalent
  • 3D CAD experience in SolidWorks, Creo or similar
  • Ability to communicate effectively across departments and with all levels of the organization
  • Project management, medical device packaging knowledge, automation experience and prior experience working in a medical device or comparable regulated industry are a plus