Senior Hardware Engineer

Must-Have Skills

• 10 years of experience in Medical Device Hardware Development
• 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 IECISO 14971 ISO 13485
• FDA Medical Device Regulations
• Manufacturing Transfer & Sustaining Engineering
• Windchill / Agile PLM

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.

Required Experience:

Senior IC