Senior Hardware Engineer – Medical Devices

Egnite HR TECH; Village of Tarrytown (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Egnite HR TECH in Tarrytown, NY seeks a Senior Hardware Engineer for medical devices to lead hardware development and sustaining activities for regulated devices. You will perform schematic reviews, component selection, PCB design reviews, and hardware validation in a cross-functional setting.

The role emphasizes risk assessments, V&V, regulatory support, and manufacturing transfers, with a focus on SI/PI, power electronics, high-speed PCB design, and compliance with IEC 60601-1/60601-1-2 and

Qualifications

• 7+ years in medical device hardware development.
• Experience with analog, digital and mixed-signal design.
• Proficiency in signal integrity and layout constraints.
• Design of MCU/FPGA interfaces and sensor integration.
• Strong background in power electronics and battery-powered devices.
• High-speed PCB design and related DA/DFM/DFT practices.
• Hardware VV/verification and risk management fundamentals.
• Regulatory knowledge for IEC 60601-1/60601-1-2 and ISO 14971.

Responsibilities

• Lead hardware design, development, and sustaining activities for regulated medical devices.
• Perform schematic reviews, component selection, and hardware validation.
• Execute risk assessments, V&V, and regulatory support activities.
• Support manufacturing transfers, supplier changes, and cost optimization.
• Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.

Skills

Medical device hardware development

Analog/digital/mixed-signal design

Signal integrity

MCU/FPGA

Power electronics

High-speed PCB design

PCB design/DFM/DFT/SI/PI

HW verification & validation

Risk management

IEC 60601-1/60601-1-2

ISO 14971

Windchill/Agile PLM

Interfaces: USB/I2C/SPI/Ethernet

Altium/OrCAD

Tools

Altium

OrCAD

Windchill/Agile PLM

Job description

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.