Embedded Systems Engineer (Medical Devices)

blackcanyonconsulting; Ashburn (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Black Canyon Consulting is seeking a mid-career Embedded Systems Engineer to bridge hardware and software for next-generation medical devices. You will architect FPGA designs on Xilinx platforms and integrate with user-space software via AXI interfaces, while also owning board schematics and power management.

You will develop Linux drivers, participate in IEC 62304/ISO 13485 processes, and collaborate with PCB/layout teams to ensure signal integrity and robust bring-up.

Qualifications

• 4–7+ years of embedded systems development experience.
• Deep knowledge of Xilinx toolchain (Vivado/Vitis) and AXI interfaces.
• Proficiency in HDL (VHDL/Verilog/SystemVerilog) for FPGA design.
• Strong embedded Linux experience with cross‑compilation and drivers.
• Fluency in C/C++ or Rust for firmware and drivers; Python for scripting.

Responsibilities

• Design and own board‑level schematics for FPGA‑based medical devices.
• Architect and implement FPGA blocks interfacing with Linux user space via AXI4 (Lite/Stream/MB).
• Develop and maintain Linux kernel drivers and user‑space libraries.
• Participate in IEC 62304/ISO 13485 compliant development lifecycle including requirements and verification.
• Collaborate with PCB/layout engineers for stack‑up, routing, and bring‑up; perform debugging and bench testing.
• Write Python scripts for hardware‑in‑the‑loop testing and automation.

Skills

FPGA design

C/C++/Rust

Linux kernel

Python scripting

Schematic capture

PCB layout guidance

Tools

Vivado

Vitis

Altium Designer

KiCad

Job description

Overview

Are you a versatile engineer who thrives at the intersection of hardware and software? Do you have a deep understanding of Xilinx FPGAs and the AXI protocol, but also enjoy diving into schematic design, PCB layout guidance, or kernel drivers when the need arises? We are seeking a dynamic, mid-career Embedded Systems Engineer to join our team developing next-generation medical devices.

In this role, you will be the linchpin between the digital logic fabric and the high-level application software. You will architect and implement complex FPGA designs that interface seamlessly with user-space applications running on embedded processors via AXI interconnects. Beyond the FPGA, you will own the board-level electronics: you'll generate detailed schematics for complex devices built around the Xilinx FPGA, ensuring robust power delivery, high-speed signal routing, and peripheral integration. We are looking for a "full-stack" embedded thinker, someone who is equally excited to design a new analog front‑end, refactor a Linux device driver, or optimize a data processing pipeline. You won't just be writing and using IP blocks; you will own the embedded ecosystem, from the circuit board to the application layer, delivering technology that directly impacts patient lives under a quality management system.

Key Responsibilities

• Board-Level Schematic Generation : Design and own the detailed electrical schematics for complex, FPGA‑centric medical devices. This includes component selection, power architecture definition, clock distribution, high-speed memory interfaces (DDR), and analog signal conditioning circuits.
• FPGA Architecture & Implementation : Design, code, and verify complex digital designs on Xilinx platforms (Vivado/Vitis), with a primary focus on implementing custom IP blocks that communicate with user‑space Linux applications via AXI4 (Lite, Stream, and Memory‑Mapped) interfaces.
• Device Driver & Kernel Development : Develop and maintain Linux kernel drivers and user‑space libraries that bridge the gap between the FPGA logic and C++/Rust/Python applications.
• Full‑Cycle Medical Device Development : Participate in all phases of the product lifecycle within a regulated IEC 62304 / ISO 13485 framework, including requirements definition, architectural design, FMEA, and verification testing.
• Cross‑Functional Hardware Integration : Work closely with PCB layout engineers to guide stack‑up and routing; perform board bring‑up, bench testing (oscilloscopes, logic analyzers), and debugging of your schematics.
• Broad Problem Solving : Demonstrate flexibility by owning problems outside any single domain. You will debug high‑speed signal integrity issues one day, and write a Python script to automate hardware‑in‑the‑loop (HIL) testing the next.
• Optimization : Profile and optimize embedded systems for low latency, high throughput, SWAP‑C (size, weight, power, and cost) constraints, and patient safety.

Must‑Have Qualifications

• Experience : 4-7+ years of hands‑on experience in embedded systems development.
• Schematic & Board Design : Proven ability to generate complex board‑level schematics for FPGA‑based designs using industry‑standard tools (e.g., Altium Designer, KiCad). Must understand power sequencing, high‑speed routing constraints, and mixed‑signal layout considerations.
• Xilinx Proficiency : Deep working knowledge of the Xilinx toolchain (Vivado, Vitis) and the ability to generate, customize, and debug IP cores connected via the AXI interconnect protocol.
• Hardware Description Languages : Proficiency in VHDL, Verilog, or SystemVerilog for synthesis, simulation, and timing closure.
• Embedded Linux : Strong experience with embedded Linux (Yocto, PetaLinux, or Buildroot), kernel configuration, and cross‑compilation.
• Software Skills : Fluency in C/C++ or Rust (preferred) for low‑level firmware and driver development; proficiency in Python for scripting and data analysis.
• Interface Knowledge : Solid understanding of communication protocols beyond AXI, such as SPI, I2C, UART, and high‑speed serial links.

Nice‑to‑Have Qualifications

• Medical Experience : Experience working in a regulated environment (FDA, MDR) with safety‑critical standards like IEC 62304.
• Analog/Digital Circuitry : Deep experience with precision analog front‑ends, ADCs, DACs, and power management ICs (PMICs) commonly found in medical instrumentation.
• Broad Toolbox : Experience with Digital Signal Processing (DSP), SoC design on Zynq/MPSoC/RFSoC platforms, or high‑speed transceivers.

Who You Are

• An Adaptable Engineer : You have deep expertise in Xilinx logic design and schematic generation, and a broad willingness and ability to contribute wherever the project needs it most, from software drivers to regulatory documentation.
• A Systems Thinker: You don't just see an FPGA task; you see the data flow from the sensor conditioning circuit, through the AXI bus, up to the UI.
• A Clear Communicator : You can translate complex hardware limitation