Senior Hardware Engineer - Medical Devices

Job Description

Senior Hardware Engineer – Regulated Industry

Location: Tarrytown, NY, USA

Visa: USC/GC/H1B/OPT

Must-Have Skills

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• 7+ years of experience in Hardware Development
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• Analog, Digital & Mixed-Signal Design,
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• Experience with signal integrity techniques and layout constraints.
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• MCU, FPGA, Sensor Interface Design
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• Power Electronics, Battery-Powered Devices, DC-DC Converters
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• High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)
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• PCB Design, DFM, DFT, SI/PI Analysis
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• Hardware Verification & Validation (V&V)
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• Hands on risk Management.
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• IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
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• Windchill / Agile PLM
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• Interfaces: USB, I2C, SPI, RS232, Ethernet, GSM, Bluetooth, Altium, OrCAD
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Preferred Skills

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• Prior experience designing medical equipment or IVD systems.
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• Experience with motion control systems, motor drivers, and precision sensors.
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Key Responsibilities

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