TransEnterix, Inc.
  • Milan, Lombardia, ITA
  • Full Time

The Manufacturing Engineer is responsible providing technical support to the Senhance manufacturing operations team. This role will work closely with our external contract manufacturer and will be responsible for coordinating production stops related to non-conformances connected to End-of-Line testing specifications. Under the direction of the MRB team, responsibilities includes helping with investigations, supporting the logistics of the tasks associated with problem resolution, creating the necessary documentation for the containment actions and executing change orders when required. This role also provides general support to other manufacturing engineering tasks as needed.

DUTIES

  • Build a strong relationship and maintain oversight to all manufacturing activities at contract manufacturer
  • Monitor, measure, and review manufacturing processes, implementing new techniques
  • Develop, oversee and revise manufacturing procedures and meet quality programs and requirements
  • Detect and present opportunities for improvements
  • Coordinate non-conformances with MRB team
  • Create documentation related to non-conformances in strict adherence to company policies and procedures
  • Generate change orders under Manager's direction using Company PLM system
  • Maintain/Create documentation related to change orders
  • Assist in special cost reduction projects
  • Create/Maintain KPI's to monitor production efficiency and improvements.
  • All Other Essential Duties as directed

QUALIFICATIONS

  • Bachelor's Degree or equivalent in electrical or mechanical engineering
  • Minimum of 3 years working experience in manufacturing/production engineering
  • Working knowledge / practical experience with ISO13485 / FDA Regulations / Medical devices
  • Experience with medical device or equivalent technical manufacturing environments/processes required
  • Proven ability to work in high performing, talented manufacturing engineering teams
  • Excellent ability to communicate ideas both orally and in writing
  • Able to relate with internal and external professionals with ease and enthusiasm
  • Proficiency with MS Office tools
  • Must be fluent in English both written and verbal
TransEnterix, Inc.
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