Sr. Hardware/Firmware Engineer

$130,000 - $160,000/Yr

The Judge Group - Worcester, MA

posted 4 months ago

Full-time - Mid Level
Worcester, MA
Administrative and Support Services

About the position

The Sr. Hardware/Firmware Engineer position at The Judge Group Inc. is a permanent/direct hire role based in Worcester, Massachusetts. This position is critical for the development of new medical products and the enhancement of existing ones. The engineer will be responsible for designing both analog and digital printed circuit boards (PCBs) that meet the stringent requirements of the medical device industry. This includes creating, testing, and releasing embedded firmware that is essential for the functionality of these medical products. The role requires a deep understanding of hardware and firmware integration, as the engineer will need to debug, integrate, and test designs at the system level to ensure they operate as intended. In addition to technical design responsibilities, the Sr. Hardware/Firmware Engineer will document and verify all hardware and firmware designs in compliance with medical device development standards. This documentation is crucial for regulatory compliance and will involve collaboration with various departments, including Research and Development (R&D), technical support, field service, and manufacturing. The engineer will also play a key role in supporting regulatory compliance efforts for medical devices, ensuring that all products meet the necessary safety and efficacy standards. The ideal candidate will have experience in analog and digital circuit design, including familiarity with Field Programmable Gate Arrays (FPGAs) and communication protocols such as SPI, I2C, CAN, RS232, Ethernet, WiFi, and Bluetooth. Proficiency in programming languages such as C, C++, and Verilog is essential, as is experience in developing embedded firmware for ARM microprocessors or equivalent. Knowledge of medical design documentation, including requirement/design specifications, risk analysis, and verification protocols/reports, is also required. The candidate should have experience in transferring new designs to production, including the development of test fixtures and procedures, and should be familiar with medical device regulatory compliance testing activities, particularly in a regulated ISO 13485 environment. A Bachelor's or Master's degree in Electrical Engineering or a related field is required for this position.

Responsibilities

  • Develop analog and digital PCB designs for new medical products and enhance existing ones.
  • Create, test, and release embedded firmware for new medical products and new features.
  • Debug, integrate, and test hardware and firmware designs at the system level.
  • Document and verify hardware and firmware designs in compliance with medical device development standards.
  • Collaborate with R&D, technical support, field service, and manufacturing departments.
  • Support medical device regulatory compliance efforts.

Requirements

  • Experience in analog/digital circuit design, including FPGAs.
  • Familiarity with communication protocols such as SPI, I2C, CAN, RS232, Ethernet, WiFi, and Bluetooth.
  • Proficient in C, C++, and Verilog programming languages.
  • Experience in developing embedded firmware for ARM microprocessors or equivalent.
  • Knowledge of medical design documentation, including requirement/design specifications, risk analysis, verification protocols/reports.
  • Experience in transferring new designs to production, including the development of test fixtures/procedures.
  • Experience in medical device regulatory compliance testing activities.
  • Experience in medical product development in a regulated ISO 13485 environment.
  • Bachelor's or Master's degree in Electrical Engineering or related field.
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