Lead Hardware Test & Pcb Design Engineer
Bedford, England, United Kingdom
I was responsible for the verification and validation for In Vitro Diagnostic (IVD) Medical Devices instrumentation platform hardware. Schematic capture, creating symbol, footprints, PCB library and PCB layout using Altium Designer, supported design and development of PSU for medical device product, ensuring the design complied with regulatory standards including EN60601, EN61010, ISO13485 and ISO14971, Defined and executed tests suites to exercise system and sub-system functionality, built test infrastructure for hardware and software rigs, Worked closely with the electronics and mechanical design team to debug any design issues, interfaced with manufacturing transfer teams to ensure successful transfer of production solution to the production factories, Developed and executed test plans and procedures based on requirement specifications using Jama, analysed, collated test results, and created test reports for internal analysis and submission for regulatory bodies, Supported the design and development of Automatic Test Equipment (ATE) and Bed of Nails.