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# Hardware Engineer - Medical Devices

- **Company:** The Apex
- **Location:** Tarrytown, NY, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Ethernet, Firmware, Field-Programmable Gate Array (FPGA), Design of User Interfaces, Hardware Design, Multipoint Control Unit, Scrum Methodology, Hardware Testing
- **Published:** August 26, 2026
- **Apply:** https://www.dice.com/job-detail/f497e499-7bc3-4218-8c40-dda21f2a5666

## About the Role

* 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

## 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.


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