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4 - 7 years

3 - 8 Lacs

Ahmedabad

Work from Office

Role & responsibilities 'Total 4-7 years of hands on system engineering experience involving electrical, mechanical, firmware out of which at least 3 years for medical devices is compulsory Proficient in product architecture design, define system interface & system verification strategy Proficient in products requirements capturing/ understanding. Proficient in product compliance testing involving mechanical, safety, EMC & environmental tests Good understanding of product reliability and functional safety Familiarity with the Design Controls in Medical Devices Experience in performing Risk Assessment & Control of the Electro-Mechanical Devices Experience in DFMEA, PFMEA, UFMEA and Software Risk Assessment Ability to review/ guide team on verification protocol for electro-mechanical medical device and define acceptance criteria Experience in prototype Manufacturing (Vendor Co-ordination, manufacturing, etc.) Understanding of handling of complete product traceability Experience working with standards such as ISO 13485, ISO 14971, IEC 60601, ISO 10993

Posted 3 months ago

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