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Senior Hardware Engineer Medical Devices

Techridge, Inc.Tarrytown, NY🇺🇸United States

Quick overview

SeniorityMid Senior
Work modeOn Site
LocationTarrytown, NY, United States
FPGAScrumAgile

Job description

Job Title: Senior Hardware Engineer Medical Devices
Location: Tarrytown, NY(Onsite)
Position Type: Contract/ Full time Opportunity
Job Description:
  • 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)
  • Requirement Traceability (RTM)
  • IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
  • FDA Medical Device Regulations
  • Manufacturing Transfer & Sustaining Engineering
  • Windchill / Agile PLM

Preferred Skills

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

Key Responsibilities

  • 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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