Member Technical Staff (Level 1)

Member Technical Staff (Level 1) responsible for producing requirements documents, running risk management activities, and providing regulatory & compliance requirements for In Vitro Diagnostic (IVD) Class II devices.

Requirements

• Produce requirements documents by coordinating with various engineering workstreams
• Run risk management activities in accordance with client defined procedure
• Produce a traceability matrix
• Provide regulatory & compliance requirements to engineering workstreams and review the artefacts
• Support in V&V activities
• Create and own the DHF as per the client's design control process