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
Employment Type: Full Time, Permanent
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