The Electrical Engineer is responsible for the design, development, testing, documentation, and release of embedded hardware and software for new and existing medical devices. This role works cross-functionally with R&D, manufacturing, technical support, and field service to ensure products meet performance, quality, and regulatory requirements throughout the product development lifecycle.
Key Responsibilities
- Design, develop, integrate, test, and release embedded hardware and software for new and existing medical devices.
- Design and test electrical schematics, support PCB development, and troubleshoot analog, digital, and mixed-signal circuits.
- Develop, implement, and validate embedded firmware using C/C++ for ARM-based microcontrollers.
- Perform system-level debugging, integration, and testing of embedded designs.
- Support design verification and validation (V&V), including test planning, execution, and documentation.
- Develop test fixtures, procedures, and tools to support the transfer of new and updated designs into production.
- Prepare and maintain software documentation in accordance with applicable medical device development standards.
- Support regulatory and quality compliance activities within an ISO 13485 environment.
- Collaborate with R&D, manufacturing, technical support, and field service teams throughout product development and production.
- Support improvements and updates to existing medical device platforms.
Qualifications & Requirements
- Bachelor's or Master's degree in Electrical Engineering.
- 3+ years of experience developing embedded hardware and software for medical devices.
- Experience with product development in a regulated ISO 13485 environment.
- Hands-on experience with embedded firmware development using C/C++ and ARM-based microcontrollers (Cortex-M/A preferred).
- Experience with analog, digital, and mixed-signal circuit design.
- Proficiency in schematic design tools such as Altium and/or OrCAD.
- Practical knowledge of communication protocols, including SPI, I2C, CAN, RS232, and Ethernet.
- Experience with design verification and validation (V&V), including test planning and execution.
- Experience transferring engineering designs into production, including developing test fixtures and procedures.
Preferred Qualifications
- Working knowledge of Python for data acquisition tools, automated testing frameworks, and validation workflows.
- Experience with FPGA firmware development using Verilog or VHDL.
- Familiarity with RTOS environments, particularly CMSIS-RTOS2 / RTX.
- Experience developing and maintaining embedded systems for regulated medical device applications.