Design control

2 weeks ago


Mysuru, India NR Consulting - India Full time
Job Description:
  • Medical device background.
  • Good understanding of medical equipment's standards, regulations, and Design Control.
  • Create / update PRTM, UNTM, DVSR and Risk management documents.
  • Hands on experience in DHF preparation.
  • Hands on experience in drafting test protocol, reports for design verification / validation.
  • Hands on experience in preparing and routing the design control documents in PLM (Preferably Windchill) for approvals.
  • Hands on experience in PLM tools (Windchill, Polarion)
  • Good Understanding of European Union Medical Devices Regulation MDR 2017/745.
  • Create/Revise documents and routing for Approval in Windchill
  • Supporting Tasks (update/revise design control documentation)
 
       Key Skills:
  • Design control
  • Risk management
  • Systems Engineering
  • Polarion
  • Teamcenter


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