Other Engineering · Contractor
Ann Arbor, MI, USA
Axiobionics LLC | Ann Arbor, Michigan
Axiobionics designs and manufactures wearable functional electrical stimulation (FES/NMES) devices that help people recover movement and independence after stroke, spinal cord injury, traumatic brain injury, and other neurological conditions — including children with cerebral palsy. Our product line, including the BioSleeve, BioShorts, TripleFlex, WalkAide, and the NeuroPro 8i controller, is built on decades of clinical research and real patient outcomes. We're a small, mission-driven medical device company based in Ann Arbor, and we're now building our next-generation muscle stimulator/EMG wearable — a device that will define the next chapter of the company.
We're looking for an Electrical / Embedded Systems Engineer to help complete the design, testing, and FDA submission readiness of our next-generation muscle stimulator / EMG wearable device. This is a hands-on engineering role: you'll work on stimulation output circuitry, EMG signal acquisition, and embedded firmware for a low-power wearable device, while also building out the design control documentation (DHF, verification and validation protocols, risk management files) required to support an FDA submission. You'll work closely with our software, quality, and clinical teams to take this device from its current state through verification, validation, and into submission-ready form.
This role is a strong fit for an engineer who wants to see their work go directly into a device that changes how people recover movement — and who's comfortable operating in both the lab and the documentation that proves the device is safe and effective.
Circuit & Hardware Design
● Design and refine stimulation output circuitry, including constant-current sources, charge-balancing, and output safety/fault-detection circuits
● Design and optimize EMG/biopotential signal acquisition circuitry: sensing, amplification, filtering, and noise reduction
● Support PCB design and layout for a compact, low-power wearable form factor
● Select components and architectures appropriate for a battery-powered, patient-worn medical device
Embedded Firmware
● Develop and maintain embedded firmware for real-time stimulation control and EMG signal processing
● Implement power management strategies appropriate for a wearable, battery-operated device
● Support wireless communication (e.g., Bluetooth Low Energy) between the device, controller, and companion software
● Collaborate with the software team on device-to-app data pipelines and control logic
Testing & Verification
● Design and execute bench testing, verification protocols, and troubleshooting for hardware and firmware
● Support electrical safety and EMC testing in alignment with IEC 60601-1 and IEC 60601-2-10 (nerve and muscle stimulators)
● Plan and execute environmental and reliability testing appropriate for a wearable medical device
● Investigate and resolve design issues identified during testing, with clear root-cause documentation
Design Controls & FDA Submission Preparation
● Develop and maintain Design History File (DHF) content: design inputs, outputs, reviews, verification, and validation records
● Author verification and validation protocols and reports in accordance with 21 CFR 820.30 design control requirements
● Contribute to the device's risk management file per ISO 14971, including FMEAs
● Support preparation of technical documentation for FDA submission (e.g., 510(k)), working closely with regulatory and quality
● Maintain full design traceability from requirements through verification and validation
Cross-Functional Collaboration
● Work day-to-day with software/firmware, quality, and mechanical/industrial design functions to keep the project moving
● Participate in design reviews and change control processes within the QMS
● Communicate technical status, risks, and timelines clearly to the broader team
● BS or MS in Electrical Engineering, Biomedical Engineering, or a related field
● Experience with embedded firmware development (C/C++) for microcontroller-based systems
● Experience with analog and mixed-signal circuit design, ideally involving stimulation output stages or biopotential signal acquisition
● Working knowledge of medical device design controls (21 CFR 820.30) and/or IEC 60601 series standards
● Experience designing for low-power, battery-operated, wearable, or portable electronic devices
● Ability to write clear technical documentation, including test protocols and reports suitable for a Design History File
● Comfortable working in a small team where you'll touch hardware, firmware, testing, and documentation
● Direct experience with FES/NMES or other electrical stimulation devices
● Experience with EMG or other biopotential sensing systems
● Experience with BLE or other wireless protocols in a medical or wearable product
● Experience supporting an actual FDA submission (510(k), De Novo, or PMA) or FDA Pre-Submission process
● Familiarity with ISO 14971 risk management and IEC 62304 (software lifecycle) for embedded medical device firmware
● The chance to be a core engineer on a next-generation medical device from design through FDA submission
● Direct, visible ownership of your work — this isn't a large team where your contributions get lost
● A mission-driven company improving quality of life for people with stroke, spinal cord injury, and cerebral palsy
Axiobionics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.