Responsibilities:
1. Deliverables for pre-Design Verification Phases:
a. Test fixtures design & fabrication with external supplier(s)
b. Test method validations
c. Preparation of hardware for software V&V and system functional testing
d. Support Electrical Design Engineers with preliminary electrical safety and EMC testing at external accredited test lab and documentation of results
2. Deliverables for Design Verification Phase:
a. Design Verification test protocols
b. Design Verification test execution and reports
c. IEC 60601-1 and IEC 60601-1-2 Testing & Certification with external accredited test lab
3. Work closely with hardware engineers and firmware developers
4. Issue Logging and Traceability management
Experience: Min. 3 Years’ Experience with Medical Device Electrical System Integration Testing and Documentation
Competencies :
1. Experienced in regulatory standards related to electrical medical devices, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, YY/T 9706, etc.
2. Proficient in using electrical laboratory equipment (oscilloscope, function generator, dataloggers, etc.)
3. Clear evidence of creative problem solving by use of tools and the tenacity and ability to overcome obstacles.
4. Experience working with software V&V engineers on integrated systems.
Preferred
1. Experience with schematic and layout tools
2. Experience with RF generating devices
