Senior Medical Systems Design Engineer (Hardware/Software)

Job ID: 7625
Job Title: Senior Medical Systems Design Engineer (Hardware/Software)
Location: Greater Boston, MA

My client seeks a highly skilled Senior Medical Systems Design Engineer to join their dynamic Engineering team. In this critical role, you will lead the design, documentation, and verification of Electronic Systems and Embedded Software for advanced medical technologies. Your expertise will directly impact the development of innovative, life-improving medical devices.

Responsibilities:

• Design, implement, test, and release analog/digital PCB designs for new medical products.
• Design, implement, test, and release embedded firmware for new medical products.
• Debug, integrate, and test hardware and embedded firmware designs at the system level.
• Lead initiatives and develop advanced projects and systems.
• Document and verify hardware and embedded firmware designs in accordance with applicable medical device development standards (e.g. requirements/design specifications, risk analysis, verification & validation protocols/reports)
• Support and interact with other departments, including R&D, technical support, field service, and manufacturing.
• Support medical device regulatory compliance efforts.
• Provide mentoring/guidance to other engineers depending on goals, objectives, and/or projects.

Requirements:

• Bachelor’s degree in Electrical Engineering
• Minimum of 8 years of work experience in hardware and embedded firmware development.
• 4 of the 8 years in an ISO 13485-compliant medical systems development environment
• Schematic Capture and PCB layout using Orcad and/or Altium.
• Analog/Digital circuit design, including FPGAs.
• Communications over SPI, I2C, CAN, RS232, Ethernet, WiFi, Bluetooth.
• Proficient in C, C++, and Verilog programming languages
• Development of embedded firmware for ARM microprocessors or equivalent
• Development of FPGA designs using Quartus Prime or equivalent
• Medical design documentation, including requirement and design specifications, risk analysis, verification protocols, and reports
• Transferring designs to manufacturing and developing test fixtures and procedures.
• Medical device regulatory compliance testing activities
• Excellent communication and interpersonal skills
• Excellent writing and analytical skills
• A highly motivated, self-starter capable of supporting multiple projects and problem-solving
• Demonstrated ability to work in a fast-paced and changing environment