Sr. system engineering

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