Hardware Engineer - Medical Devices

The Apex

Tarrytown, NY, United States

11 days ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

10 years minimum

Working hours

Regular working hours

Job source

www.dice.com

Tech stack

Ethernet Firmware Field-Programmable Gate Array (FPGA) Design of User Interfaces Hardware Design Multipoint Control Unit Scrum Methodology Hardware Testing

Job description

Lead hardware design, development, and sustaining engineering activities for regulated medical devices.
Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.
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.

Requirements

10+ years of experience in Medical Device Hardware Development
Analog, Digital & Mixed-Signal Design
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
CAPA, NCR, Change Control & Obsolescence Management
Component Qualification & Alternate Part Evaluation
Hardware Verification & Validation (V&V)
Risk Management (dFMEA, pFMEA, sFMEA), * IVD / Clinical Diagnostics / Medical Equipment
Cost Reduction, VAVE & Should-Cost Analysis
Safety & EMC Compliance Testing
Supplier Qualification & Product Lifecycle Management
Agile / Scrum Project Execution