Senior Medical Hardware Engineer - Regulated Devices Lead

Techridge, Inc.; Village of Tarrytown (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Techridge, Inc. in New York seeks a senior hardware engineer for medical device hardware development.

You will lead design, development, and sustaining engineering for regulated medical devices, performing schematic reviews, component selection, and hardware validation. You will execute risk assessments, V&V, compliance testing, and regulatory support, and you will collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams to ensure robust, compliant products

Qualifications

• Must have 10/15 years of experience in Medical Device Hardware Development.
• Experience with Analog, Digital & Mixed-Signal design and signal integrity techniques.
• Hands-on hardware V&V and regulatory support.
• Knowledge of IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485.
• Experience with Windchill/Agile PLM and interface standards USB, I2C, SPI, RS232, Ethernet.

Responsibilities

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

Skills

Medical device hardware

Analog & mixed-signal

Signal integrity

MCU & FPGA

Sensor interface

Power electronics

High-speed PCB

PCB design reviews

V&V

Regulatory risk

Windchill PLM

USB / I2C / SPI interfaces

Altium

OrCAD

Tools

Altium

OrCAD

Windchill

Agile PLM

USB

I2C

SPI

Job description

Techridge, Inc. in New York seeks a senior hardware engineer for medical device hardware development.

You will lead design, development, and sustaining engineering for regulated medical devices, performing schematic reviews, component selection, and hardware validation. You will execute risk assessments, V&V, compliance testing, and regulatory support, and you will collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams to ensure robust, compliant products