Sapsol Technologies

Senior Hardware Engineer

Board & Electronics DesignConfirmed live in the last 24 hours

Full-timeTarrytown, NY, USANo salary listedIn-person

At least 10 years of experience in medical device hardware development.
Experience with analog, digital, and mixed-signal design.
Experience with MCU, FPGA, and sensor interface design.
Experience with power electronics, battery-powered devices, and DC-DC converters.
Experience with high-speed PCB design and Ethernet, USB, SPI, I2C, and CAN.
Experience with PCB design, design for manufacturability, design for test, and signal/power integrity analysis.
Experience with CAPA, nonconformance reports, change control, and obsolescence management.
Experience with component qualification and alternate part evaluation.
Experience with hardware verification and validation.
Experience with risk management, including dFMEA, pFMEA, and sFMEA.
Experience with requirement traceability matrices.
Knowledge of IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 13485.
Knowledge of FDA medical device regulations.
Experience with manufacturing transfer and sustaining engineering.
Experience with Windchill or Agile PLM.

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, verification and validation, 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.

Sapsol Technologies Inc · Tarrytown, United States · — · Posted 2026-09-09

Workplace: on_site

Must-Have Skills

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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