Company Overview
Leading medical technology company
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Job Description
Technical Skill Set
Practical implementation of Risk Management of Medical Device per ISO 14971.
Experience with Risk Analysis tools and techniques.
Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.
Experience on Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).
Understanding of electrical & embedded component’s working principle and functionality.
Understanding of various documentation required during HDLC & SDLC.
Familiarity with IEC 60601-1 family of standards.
Familiarity with any basic programming language, embedded software & tools.
Understanding of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).
Requirements
Embedded domain