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X4 Life Sciences · Massachusetts, United States

FPGA Engineer

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Stack mentioned

embedded-systems

Principal FPGA Engineer - Medical Diagnostics

X4 Life Sciences are partnered with an innovative medical diagnostics company seeking a Principal FPGA Engineer to provide technical leadership in the development and sustainment of next-generation diagnostic systems.

This is a high-impact senior role where you will lead FPGA architecture, HDL development, verification, integration, and system-level design within a regulated medical device environment, while also driving process maturity and cross-functional alignment across hardware and software teams.

Key Responsibilities:

- Lead FPGA architecture definition, HDL design, verification, validation, and release activities

- Own FPGA integration within hardware and embedded software system architectures

- Serve as a technical authority across hardware, software, and systems engineering teams

- Perform complex technical trade-off analyses and drive engineering decisions

- Support system-level debugging, troubleshooting, and product release activities

- Lead and mentor engineers while influencing technical direction across projects

- Support CAPA, complaint investigations, and continuous improvement initiatives

- Drive improvements in FPGA/firmware development processes and engineering workflows

- Ensure disciplined documentation and predictable execution of engineering work

- Identify and mitigate engineering risks, especially in sustaining/obsolescence programs

Key Requirements:

- Strong FPGA technical background is essential

- Extensive experience in regulated environments (IVD medical device experience strongly preferred)

- Proven ability to work within regulated release processes

- Ability to understand, own, and improve modern software/firmware processes

- Experience collaborating with software teams is important, as the FPGA work sits in the hardware group but interfaces closely with software.

- Strong documentation skills (design specs, code documentation, interface definitions, handover materials)

- Ability to manage risk in engineering changes, especially in sustaining engineering and obsolescence programs

- Organized, process-driven, and able to plan, execute, and document work in a predictable way

Preferred Skills & Tools:

- Vivado

- Xilinx / AMD FPGA platforms

- Artix-7

Key Skills:

- FPGA Architecture & Design Leadership

- HDL Development (VHDL/Verilog)

- Regulated Product Development

- Firmware & Software Process Improvement

- System Integration & Debugging

- Risk Management in Sustaining Engineering

- Technical Documentation & Specifications

- Cross-functional Collaboration (Hardware & Software)

- Technical Leadership & Mentoring

If you are interested, or know someone who is, please reach out to [email protected]

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