Senior Hardware Engineer - Medical Devices

Senior Hardware Engineer – Medical Devices

Location: Tarrytown, NY, USA

Visa: USC/GC/H1B

Must-Have Skills

• 7+ years of experience in Medical Device Hardware Development
• Analog, Digital & Mixed-Signal Design,
• Experience with signal integrity techniques and layout constraints.
• 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
• Hardware Verification & Validation (V&V)
• Hands on risk Management.
• IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
• Windchill / Agile PLM
• Interfaces: USB, I2C, SPI, RS232, Ethernet, GSM, Bluetooth, Altium, OrCAD

Preferred Skills

• Prior experience designing medical equipment or IVD systems.
• Experience with motion control systems, motor drivers, and precision sensors.

Key Responsibilities

• Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
• 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.