Senior Hardware Engineer – Medical Devices at TEKFORTUNE INC in Tarrytown, NY

Job description

• Job Description

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.

Requirements

• 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, Client, Change Control & Obsolescence Management
• Hardware Verification & Validation (V&V)
• Risk Management (dFMEA, pFMEA, sFMEA)
• FDA Medical Device Regulations
• Manufacturing Transfer & Sustaining Engineering
• Windchill / Agile PLM
• IVD / Clinical Diagnostics / Medical Equipment
• Cost Reduction, VAVE & Should-Cost Analysis
• Safety & EMC Compliance Testing
• Agile / Scrum Project Execution

Skills

Required

• Analog, Digital & Mixed-Signal Design
• MCU, FPGA, Sensor Interface Design
• PCB Design, DFM, DFT, SI/PI Analysis
• Hardware Verification & Validation (V&V)
• Risk Management (dFMEA, pFMEA, sFMEA)
• Requirement Traceability (RTM)
• FDA Medical Device Regulations
• Windchill / Agile PLM

Preferred

• Safety & EMC Compliance Testing
• Agile / Scrum Project Execution