Principal Engineer

X4 Life Sciences; Massachusetts; On-site; USD 120,000 - 150,000; Full time

Job summary

X4 Life Sciences is seeking a Principal FPGA Engineer to provide technical leadership in medical diagnostics. You will lead FPGA architecture, HDL development, and integration within a regulated environment.

The successful candidate will have a strong FPGA background, experience in regulated environments, and demonstrated leadership skills. This role involves collaboration with hardware and software teams to drive product development and improvements.

Qualifications

• Strong FPGA technical background essential.
• Extensive experience in regulated environments, IVD medical device experience preferred.
• Proven ability to work within regulated release processes.
• Strong understanding of FPGA/firmware lifecycle and modern engineering processes.
• Demonstrated ability to identify gaps in engineering processes and implement improvements.
• Experience collaborating with software teams on hardware/software interface design.
• Ability to manage risk in engineering changes, especially in sustaining engineering.

Responsibilities

• Lead FPGA architecture definition, HDL design, verification, and release activities.
• Own FPGA integration within system architectures.
• Serve as a technical authority across engineering teams.
• Support debugging and troubleshooting activities for product releases.
• Lead and mentor engineers while influencing technical direction.

Skills

Regulated Product Development

Firmware & Software Process Improvement

Risk Management in Sustaining Engineering

Technical Documentation & Specifications

Cross-functional Collaboration (Hardware & Software)

Technical Leadership & Mentoring

Tools

Xilinx / AMD FPGA platforms

Artix-7

Job description

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
• Strong understanding of FPGA/firmware lifecycle and modern engineering processes
• Demonstrated ability to identify gaps in engineering processes and implement improvements
• Experience collaborating closely with software teams on hardware/software interface design
• 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:

• Xilinx / AMD FPGA platforms
• Artix-7

Key Skills:

• Regulated Product Development
• Firmware & Software Process Improvement
• Risk Management in Sustaining Engineering
• Technical Documentation & Specifications
• Cross-functional Collaboration (Hardware & Software)
• Technical Leadership & Mentoring