, SI/PI Analysis Hardware Verification & Validation (V&V) Hands on risk Management. IEC 60601-1, IEC 60601-1-2, ISO 14971...
Job Responsibilities Support medical device software development teams in applying design controls and IEC 62304 software lifecycle.... At least 3 years of experience supporting regulated software or systems development. Working knowledge of IEC 62304, design...
942, IEC 61300 3 35, and procedure driven work. Proficiency in fiber management and DCIM style systems of record...
goals in a matrixed environment. Demonstrates understanding of and adherence to FDA, ISO, IEC design control procedures...
: Wireless stacks (BLE, Wi Fi, Thread, Zigbee) Edge AI DSP ISO 26262, IEC 62304, MISRA C/C++ Detailed... (ISO 26262, IEC 62304, MISRA C/C++). Experience with wireless stacks (BLE, Wi Fi, Thread, Zigbee), edge AI, or DSP...
endpoints, segmentation, encryption and Zero Trust. Align designs to relevant frameworks and regulations, such as IEC 62443... model, network segmentation, IEC 62443 concepts). Excellent communication, ability to work credibly with both IT...
with applicable quality-system procedures. Ensure that embedded software development follows IEC 62304 lifecycle processes. Support... following: IEC 62304. ISO 13485. ISO 14971. FDA Design Controls. FDA 21 CFR Part 820. FDA guidance for medical-device...
complex electrical and embedded system challenges. Experience with IEC 60601 electrical safety and EMC standards... Device safety requirements such as IEC 60601 and other Medical Device standards. Ensure duties are completed according...
, or relevant OT security certifications (e.g., ISA/IEC 62443). Deep understanding of cybersecurity fundamentals such as networking... Protocols such as DNP3, Modbus, IEC 104, OPC UA, including packet analysis and understanding protocol vulnerabilities...
and/or engineer of record. Strong knowledge of international civil and design standards (IEC, BS, IEEE, ANSI etc.). Experience...