Electrical Hardware Engineer

Trident Consulting IncBurlington, MA
$50 - $58Onsite

About The Position

Seeking a Senior Electrical Engineer to design, develop, and support advanced electro-opto-mechanical medical devices. The role focuses on circuit design, PCB development, system integration, verification, validation, and compliance within FDA-regulated and ISO13485 environments.

Requirements

  • Bachelor's or Master's degree in Electrical Engineering or related field.
  • 5+ years of electrical engineering experience.
  • Strong experience in analog, digital, mixed-signal, power electronics, and PCB design.
  • Hands-on experience with Altium Designer, PSpice, LTspice, MATLAB/Simulink, Allegro PCB, and ORCAD.
  • Experience with signal integrity, power integrity, thermal analysis, and EMC/EMI simulations.
  • Knowledge of I2C, SPI, UART, CAN, Wi-Fi, and BLE communication protocols.
  • Experience with motor control circuits, sensor integration, and hardware validation.
  • Familiarity with FDA-regulated product development, QMS, and ISO13485 environments.
  • Strong troubleshooting, analytical, and cross-functional collaboration skills.

Nice To Haves

  • Medical device industry experience.
  • Experience with regulated product development and compliance testing.
  • Hands-on system integration and verification experience.

Responsibilities

  • Design analog, digital, mixed-signal, and power electronic circuits.
  • Perform schematic capture, multi-layer PCB layout, board bring-up, testing, and debugging.
  • Conduct circuit simulations, signal integrity, power integrity, EMC/EMI, thermal, and reliability analyses.
  • Develop electrical wiring diagrams and integrate sensors, motors, displays, power supplies, and communication interfaces.
  • Manage PCB design environments, component libraries, configuration management, and revision control.
  • Support prototype builds, root-cause analysis, hardware troubleshooting, and system integration.
  • Define and execute verification and validation protocols.
  • Generate technical documentation, design records, and test reports.
  • Support ECOs, CAPA investigations, manufacturing issues, and component obsolescence management.
  • Ensure compliance with FDA design controls, ISO13485, IEC 60601-1, and IEC 60601-1-2 standards.
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