Senior Electrical Engineer – Medical Devices, FPGA & Firmware Lead

Harba Solutions Inc.; Raleigh (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

Harba Solutions Inc. seeks a Senior Electrical Engineer to lead the design, development, and analysis of electronic hardware and embedded firmware for medical devices.

The role emphasizes mixed-signal PCBA design, FPGA/Verilog/VHDL work, and system-level engineering in collaboration with hardware and software teams and external partners. You will prototype in the lab, validate designs, develop verification plans, ensure IEC 60601, EMC compliance, and risk management per ISO 14971, IEC 62304, and

Qualifications

• Bachelor's degree in Electrical Engineering, Systems Engineering, or related 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.

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.

Skills

Mixed-signal design

Embedded firmware development

FPGA development

Verilog

VHDL

Electrical safety knowledge

Risk management (ISO 14971)

IEC 62304

IEC 60601

EMC

Education

Bachelor's degree in Electrical Engineering

Job description

Harba Solutions Inc. seeks a Senior Electrical Engineer to lead the design, development, and analysis of electronic hardware and embedded firmware for medical devices.

The role emphasizes mixed-signal PCBA design, FPGA/Verilog/VHDL work, and system-level engineering in collaboration with hardware and software teams and external partners. You will prototype in the lab, validate designs, develop verification plans, ensure IEC 60601, EMC compliance, and risk management per ISO 14971, IEC 62304, and