Hardware Engineer

Saxon Global; Village of Tarrytown (NY); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analog, digital & mixed-signal design

Signal integrity techniques

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

Risk management

IEC 60601-1

IEC 60601-1-2

ISO 14971

ISO 13485

Windchill / Agile PLM

Altium

OrCAD

Strumenti

Altium

OrCAD

Windchill

Agile PLM

Descrizione del lavoro

Job – Senior Hardware Engineer – Medical Devices

Job Type – Full time

Must-Have Skills

• 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