Design Control

Year Mysore, Karnataka, India

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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:

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