Senior Engineer BA - Medical Device Arrow Electronics India Pvt Ltd

Senior Engineer (BA - Medical Device)

Position:

Job Description:

• Scope of the device: This is an in vitro diagnostic (IVD) Class II device that is used in Laboratories or Clinics as a tabletop device for blood gas analysis through a variety of hemolysis techniques. 
• Key task of this role:
  • Produce requirements documents by coordinating with various engineering workstreams
  • Run risk management activities in accordance with client-defined procedure
  • Produce traceability matrix 
  • Provide regulatory & compliance requirements to engineering workstreams and review the artifacts
  • Support in V&V activities
  • Create and own the DHF as per the client's design control process 
  • Good understanding of Medical device regulations: ISO 13485, ISO 14971, IEC 62304, IEC 60601

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Experience Level