Senior Hardware Engineer

<h2>Must-Have Skills</h2><ul>
<li>10+ years of experience in<strong>Medical Device Hardware Development</strong>
</li>
<li>Analog, Digital &amp; Mixed-Signal Design</li>
<li>MCU, FPGA, Sensor Interface Design</li>
<li>Power Electronics, Battery-Powered Devices, DC-DC Converters</li>
<li>High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)</li>
<li>PCB Design, DFM, DFT, SI/PI Analysis</li>
<li>CAPA, NCR, Change Control &amp; Obsolescence Management</li>
<li>Component Qualification &amp; Alternate Part Evaluation</li>
<li>Hardware Verification &amp; Validation (V&amp;V)</li>
<li>Risk Management (dFMEA, pFMEA, sFMEA)</li>
<li>Requirement Traceability (RTM)</li>
<li>IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485</li>
<li>FDA Medical Device Regulations</li>
<li>Manufacturing Transfer &amp; Sustaining Engineering</li>
<li>Windchill / Agile PLM</li>
</ul><h2>Key Responsibilities</h2><ul>
<li>Lead hardware design, development, and sustaining engineering activities for regulated medical devices.</li>
<li>Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.</li>
<li>Perform schematic reviews, component selection, PCB design reviews, and hardware validation.</li>
<li>Execute risk assessments, V&amp;V, compliance testing, and regulatory support activities.</li>
<li>Support manufacturing transfers, supplier changes, and cost optimization programs.</li>
<li>Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.</li>
</ul>