Senior Electrical Engineer

Job Description

Overview

We are seeking a Senior Electrical Engineer to lead the design, development, and analysis of electronic hardware and embedded firmware for new and existing medical device products. This role will focus heavily on mixed-signal PCBA design, embedded C/C++ firmware development, and system-level engineering. The Senior Electrical Engineer will work hands-on in the lab to prototype, troubleshoot, debug, and validate electrical designs while partnering with internal hardware and software teams and external design partners. This individual will play a key role in developing system requirements, designing hardware and firmware architectures, and executing verification and validation activities to ensure products meet technical, quality, and regulatory requirements.

Job Responsibilities

• Lead electrical and embedded firmware design and development for new and existing medical device products, including system-level, sub-assembly, and board-level circuits.
• Develop and manage system, sub-assembly, and board-level requirements and specifications.
• Design and develop mixed-signal PCBA hardware, including digital and analog circuits, power supplies, amplifiers, and embedded systems.
• Develop embedded firmware using C/C++, Verilog, and VHDL to support hardware functionality.
• Support FPGA and microcontroller design and development.
• Perform system integration, verification, and validation activities, including developing test plans and executing engineering tests.
• Lead electrical root cause investigations for product quality issues, failures, and design enhancements, implementing corrective actions as needed.
• Provide electrical and firmware engineering support throughout the product lifecycle, including manufacturing support and existing product improvements.
• Ensure designs meet applicable medical device safety, quality, and regulatory standards, including IEC 60601 and EMC requirements.
• Collaborate with internal engineering teams and external design partners to execute project work packages and meet technical requirements, schedules, and cost targets.
• Conduct engineering analysis, feasibility studies, and technical assessments to support product development decisions.
• Follow established design control procedures and contribute to process improvements.

Job Requirements

• Bachelor's degree in Electrical Engineering, Systems Engineering, or a related engineering field.
• 7+ years of experience with mixed-signal design utilizing FPGAs.
• 5+ years of engineering experience in the medical device industry or another highly regulated engineering environment.
• Experience with embedded firmware development and exposure to software development practices, including IEC 62304.
• Strong understanding of mixed-signal circuit design and high-speed PCB layout considerations, including parasitics, crosstalk, grounding, power supply noise, and EMI.
• Experience with FPGA development using Verilog and/or VHDL.
• Knowledge of electrical safety and EMC requirements, particularly IEC 60601.
• Strong understanding of medical device risk management and risk analysis techniques, including ISO 14971.
• Experience developing verification strategies, test plans, and executing design verification activities.
• Ability to troubleshoot complex electrical and embedded system issues and lead root cause investigations.