Technical Staff - Medical Device Engineering

Member Technical Staff (Level 1)

Position:

Member Technical Staff (Level 1)

Job Description:

Job Summary:

• Scope of the device: In Vitro Diagnostic (IVD) Class II device, which is used in Laboratories or Clinics as a table-top device for blood gas analysis through variety of hemolysis techniques. 
• Key ask of this role:
  • 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 
  • Good understanding of Medical device regulations: ISO 13485, ISO 14971, IEC 62304, IEC 60601

Location:

IN-GJ-Ahmedabad, India-Ognaj (eInfochips)

Time Type:

Full time

Job Category:

Engineering Services

Experience Level

Senior Level