Senior Hardware Engineer (FPGA/PCB Design/V&V/ IEC-60601)

Job title : Senior Hardware Engineer (FPGA/PCB Design/V&V/ IEC-60601)

Job Description:

Skills:

• 10+ years of experience in Hardware Development (medical devices preferred)
• Analog, Digital & Mixed-Signal Design MCU, FPGA, Sensor Interface Design Power Electronics, Battery-Powered Devices, DC-DC Converters High-Speed.
• PCB Design (Ethernet, USB, SPI, I2C, CAN) PCB Design, DFM, DFT, SI/PI Analysis CAPA, NCR.
• Change Control & Obsolescence Management Component Qualification & Alternate Part Evaluation Hardware Verification & Validation (V&V) Risk Management (dFMEA, pFMEA, sFMEA).
• Requirement Traceability (RTM) IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485 FDA Medical Device Regulations Manufacturing Transfer & Sustaining Engineering Windchill / Agile PLM

Preferred Skills:

• IVD / Clinical Diagnostics / Medical Equipment Cost Reduction, VAVE & Should-Cost Analysis Safety & EMC Compliance Testing Supplier Qualification & Product Lifecycle Management Agile / Scrum Project Execution

Key Responsibilities:

• Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
• Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.
• Perform schematic reviews, component selection, PCB design reviews, and hardware validation.
• Execute risk assessments, V&V, compliance testing, and regulatory support activities.
• Support manufacturing transfers, supplier changes, and cost optimization programs.
• Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.