Senior Medical Hardware Engineer – Regulated Devices

Saxon Global

Village of Tarrytown (NY)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

Saxon Global is seeking a Senior Hardware Engineer to lead hardware development for regulated medical devices in a fast-paced team. You will drive schematic reviews, component selection, and hardware validation to ensure compliance and safety.

Responsibilities include risk assessments, V&V, regulatory support, and manufacturing transfers. Collaboration with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams is essential.

Qualifications

Analog, digital and mixed-signal design expertise with SI techniques.
MCU/FPGA and sensor interface design experience.
Power electronics for battery-powered devices and DC-DC converters.
High-speed PCB design (Ethernet, USB, SPI, I2C, CAN).
PCB design with DFM/DFT and SI/PI analysis.
Hardware verification and validation (V&V).
Hands-on risk management and regulatory awareness.
IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485.
Windchill/Agile PLM and interfaces (USB, I2C, SPI, RS232, Ethernet, GSM, Bluetooth); tools Altium/OrCAD.

Responsibilities

Lead hardware design, development, and sustaining engineering 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.
Support manufacturing transfers, supplier changes, and cost optimization programs.
Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.