Design control
2 weeks ago
- 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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