Mechanical Engineer
. Additional Skills & Qualifications Experience with IEC -1 and ISO Risk Management for Medical Devices. Proficiency in using...
. Additional Skills & Qualifications Experience with IEC -1 and ISO Risk Management for Medical Devices. Proficiency in using...
knowledge of IEC 60601 and/or 62304. If this job is a match for your background, we would be honoured to receive...
Familiarity with standards such as IEC 81001-5-1 and IEC 62304 Experience with threat modeling Experience with SBOMs (Software...
with communication protocols: IEC 101/104, DNP3, Modbus, ICCP. Working experience on Linux and Windows platforms. Knowledge of network...
migration projects for in-house manufacturing software tools Knowledge of ISO 13485 and FDA QSR. Working knowledge of IEC...
verification and validation following IEC 62304. Support risk management efforts aligned with ISO 14971. Participate in audits... understanding of Linux internals and embedded systems. Experience in regulated environments. Knowledge of IEC 62304, ISO 14971...
Familiarity with IEC standards: IEC 61215, 61646, 61730 Ability to independently handle specialized technical tasks...
mechanisms. Support cybersecurity risk analysis and threat modeling. Perform OS-level verification and validation following IEC... systems. Experience in regulated environments. Knowledge of IEC 62304, ISO 14971, and related standards. Familiarity...
PE license or ability to obtain is a plus. Experience with UL891, UL1558, and IEC standards. Knowledge of thermal management...
bridged the gap between agile velocity and strict safety certification (e.g., DO-178C, IEC 62304). Regulatory Fluency...