Embedded Systems Engineer Medical Devices - Black Canyon Consulting

Polluxa, Inc.; Washington; On-site; USD 90,000 - 130,000; Full time

Job summary

Polluxa, Inc. is seeking a mid-career Embedded Systems Engineer to bridge hardware and software in next-gen medical devices.

You will own FPGA designs on Xilinx platforms, interface with user-space apps via AXI, and lead board-level electronics from schematics to power delivery. You'll collaborate with PCB layout engineers, write Linux drivers, and contribute to a fully regulated development lifecycle under IEC 62304 / ISO 13485; a full-stack embedded mindset is required.

Qualifications

• Experience with Xilinx FPGAs and AXI interfaces.
• Proficiency in FPGA-to-software integration for embedded Linux.
• Background in schematic design, PCB layout, or kernel drivers.
• Familiarity with IEC 62304 / ISO 13485 is a plus.
• Ability to work across hardware and software domains.

Responsibilities

• Board-Level Schematic Generation for FPGA-centric devices.
• FPGA Architecture & Implementation on Xilinx platforms.
• Device Driver & Kernel Development for Linux.
• Full-Cycle Medical Device development under IEC 62304/ISO 13485.
• Cross-Functional hardware integration and debug.
• Broad problem solving across domains including HIL testing.

Skills

FPGA design

AXI protocols

Linux kernel drivers

Embedded software

Schematic design

PCB layout guidance

Tools

Vivado/Vitis

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.