SAPSOL Technologies Inc.
SAPSOL Technologies Inc.

Senior Hardware Engineer

Tarrytown, NY, US • Posted 30+ days ago • Updated 8 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Mixed-signal Integrated Circuit
  • MCU
  • FPGA
  • Sensors
  • Interface Design
  • Power Electronics
  • Ethernet
  • USB
  • SPI
  • I2C
  • Design For Manufacturability
  • DFT
  • NCR
  • Change Control
  • Management
  • Evaluation
  • Verification And Validation
  • Risk Management
  • FMEA
  • RTM
  • ISO 9000
  • ISO 13485
  • Windchill
  • Agile PLM
  • Hardware Development
  • Medical Devices
  • Corrective And Preventive Action
  • Change Management
  • Product Optimization
  • PCB Design
  • Computer Hardware
  • Risk Assessment
  • Regulatory Compliance
  • Testing
  • Optimization
  • Collaboration
  • Firmware
  • Mechanical Engineering
  • Manufacturing

Summary

Must-Have Skills
  • 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

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 90941421
  • Position Id: 4d0b04332f8be49a9c7b3edcbad10036
  • Posted 30+ days ago
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