Senior Medical Device Hardware Engineer | Regulated Systems

Egnite HR TECH

Village of Tarrytown (NY)

On-site

USD 120,000 - 170,000

Full time

8 days ago

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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.