Embedded Systems Engineer (Medical Devices)

Black Canyon Consulting; Ashburn (VA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan with employer contribution

Paid holidays and vacation

Tuition reimbursement

Job summary

Black Canyon Consulting is seeking an Embedded Systems Engineer (Medical Devices) in Ashburn, VA to bridge hardware and software across FPGA, PCBs, and kernel drivers. You will architect FPGA cores, generate schematics, and integrate with embedded Linux applications.

The role emphasizes full‑stack ownership from circuit boards to patient‑facing software within a regulated quality framework (IEC 62304 / ISO 13485), with a focus on low‑latency, high‑throughput embedded systems.

Qualifications

• 4–7+ years of hands‑on embedded systems experience.
• Ability to generate complex board‑level schematics for FPGA‑based designs.
• Deep working knowledge of Xilinx toolchain (Vivado, Vitis) and AXI interconnects.
• Proficiency in VHDL/Verilog/SystemVerilog for synthesis, simulation, timing.
• Strong experience with embedded Linux (Yocto, PetaLinux, Buildroot).
• Fluency in C/C++ or Rust for firmware and driver development; Python scripting.

Responsibilities

• Design and own FPGA architectures and IP cores interfacing with user‑space Linux apps via AXI interfaces.
• Generate and own detailed schematics for FPGA‑centric medical devices; define power architecture and high‑speed routing.
• Develop and maintain Linux kernel drivers and user‑space libraries bridging FPGA logic and applications.
• Participate in IEC 62304 / ISO 13485 regulated development lifecycle (requirements, architecture, verification).
• Collaborate with hardware for board bring‑up, testing, and debugging; optimize signal integrity and timing.

Skills

Xilinx FPGA

VHDL/Verilog/SystemVerilog

Embedded Linux

C/C++ or Rust

Python

Schematic/PCB design

AXI interconnect

Tools

Vivado

Vitis

Altium Designer

KiCad

Job description

Embedded Systems Engineer (Medical Devices)

Ashburn, VA

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 limitations to software engineers and vice versa, documenting your work clearly for regulatory audits.

Benefits and Salary

We attract the best people in the business with our competitive benefits package, including medical, dental, and vision coverage; a 401(k) plan with employer contribution; paid holidays, vacation, and tuition reimbursement.

We offer a competitive salary commensurate with experience and location.