Job Description

Job Description

Job Title: Senior Hardware Engineer

Location : Tarrytown, NY (Onsite)

Position Overview

We are seeking an experienced Senior Hardware Engineer to lead the design, development, verification, and sustaining engineering of regulated medical device hardware. The ideal candidate will have extensive experience developing analog, digital, and mixed-signal electronics, along with a strong understanding of medical device regulations, hardware verification and validation, risk management, and manufacturing processes.

Key Responsibilities

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

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• 10+ years of experience in Device Hardware Development
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• Analog, Digital & Mixed-Signal Design
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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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• CAPA, NCR, Change Control & Obsolescence Management
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• Component Qualification & Alternate Part Evaluation
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• Hardware Verification & Validation (V&V)
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• Risk Management (dFMEA, pFMEA, sFMEA)
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• Requirement Traceability (RTM)
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• IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
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• FDA Medical Device Regulations
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• Manufacturing Transfer & Sustaining Engineering
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• Windchill / Agile PLM
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Preferred Skills

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• IVD / Clinical Diagnostics / Medical Equipment
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• Cost Reduction, VAVE & Should-Cost Analysis
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• Safety & EMC Compliance Testing
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• Supplier Qualification & Product Lifecycle Management
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• Agile / Scrum Project Execution
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