Hardware Engineer

JD:<br /> <br /> Design and develop analog and digital hardware components for electromechanical medical devices.<br /> Create schematics, PCB layouts, and hardware architecture in compliance with product requirements.<br /> Select and qualify components considering performance, reliability, and regulatory constraints.<br /> Collaborate with mechanical and software teams to ensure seamless system integration.<br /> Develop and execute hardware verification plans including functional, electrical safety, EMC, and environmental testing.<br /> Support design verification and validation activities in alignment with IEC 60601 and ISO 80601 standards.<br /> Troubleshoot and debug hardware issues during development and testing phases.<br /> Document test procedures, results, and compliance evidence for regulatory submissions.<br /> Ensure hardware design complies with - IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), ISO 13485 (Quality Management Systems), FDA 21 CFR Part 820.30 (Design Controls)<br /> Collaborate with manufacturing and supply chain teams for design transfer and production readiness.<br /> Support DFM (Design for Manufacturability) and DFA (Design for Assembly) initiatives.<br /> Proficient in hardware and simulation tools.<br /> Maintain documentation including schematics, BOMs, test reports, and change records.<br /> Work closely with systems, software, mechanical, and quality teams to ensure hardware meets system-level requirements.