Summary

The Manufacturing engineer is responsible for sustaining and continuous improvement support of production to achieve operational objectives.  This person will part of a team that drives continuous improvement to achieve better product quality, availability and operational margin.  

Essential Duties

Primary QMS Responsibilities:

  • Validate and implement manufacturing scale-up to meet business objectives.
  • Develop and maintain processes, tooling, and documentation necessary to ensure the consistent manufacture of products.
  • Create manufacturing specifications and validate test method for in-process QC.
  • Create standard operating procedures and train operation for the manufacturing of products.
  • Perform manufacturing process improvements to achieve better product quality, availability and operational margin.
  • Ensure personnel are properly trained (safety and quality) on key processes and equipment.
  • Contribute and drive actions in support of critical on-time delivery to manufacturing schedule.
  • Monitor / track production process metrics and acts to ensure they meet established standards.
  • Ensure a high standard of product quality in accordance with ISO and the company Quality Manual.
  • Develop infrastructure to sustain established processes while pushing for scale-up capabilities.
  • Provide guidance and training to technicians to better support manufacturing.

Primary Non-QMS Responsibilities:

  • Drive technical projects from conceptual to qualifications to scale-up and sustaining.
  • Trouble-shoot and sustain manufacturing process / equipment.
  • Develop and mentor teams to support operational needs.
  • Other duties as assigned

Education and/or Experience

  • Bachelor’s degree in Engineering or equivalent.
  • 2-5 years of progressive experience in a technical role (mechanical, electromechanical, and / or automation experiences a plus).
  • Experience with ISO-13485 high volume / single use disposable a plus.

Other Qualifications

  • Strong interpersonal and communication skills.
  • Ability to drive a technical project from start to finish within an established QMS system.
  • Diverse technical background with demonstrated accomplishments.
  • SolidWork proficiency.
  • Strong computer literacy in MS Office (Work, Excel, PowerPoint, etc.) and ERP systems.

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 20 lbs.

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