Job Title: Principal Firmware Engineer

Company: Adraxe

Job Type: Full-Time

Location: Plymouth, MN (Hybrid)

Adraxe - Company Overview

Adraxe Corporation is an innovative medical device startup focused on the design, development, and launch of breakthrough, minimally invasive neuromodulation solutions to address unmet patient needs. The results from the first clinical epilepsy patients are encouraging and we are at the important stage of hiring key personnel, to accelerate our progress and starting our full product and clinical development. Our goal is to revolutionize neurological care with life-compatible, closed-loop neuromodulation therapies, starting with epilepsy.

About the role
This Principal Embedded Software Engineer will lead the design and development of safety-critical firmware for advanced implantable neurostimulator systems. The person in this roll will architect, implement, and verify embedded software that drives closed-loop neural stimulation and sensing technologies, enabling life-changing therapy for patients with epilepsy.

As a senior technical leader, you will work closely with cross-functional teams—including systems, hardware, firmware, and clinical engineering—to deliver innovative and compliant software solutions that meet stringent regulatory and performance standards.

This position will report directly to the VP and Chief engineer and will have significant input into Adraxe strategy, planning, and operations.

What you'll do

• Leading the embedded software development lifecycle for implantable and external neurostimulator components, from concept through verification and release
• Architecting and implementing real-time embedded software for neural stimulation control, sensing, and wireless telemetry (implant-to-external communication)
• Developing algorithms and control loops for stimulation pattern generation, current regulation, and neural signal acquisition and processing
• Ensuring compliance with IEC 62304 (software life cycle), ISO 14971 (risk management), ISO 13485 (quality systems), and FDA/MDR design control requirements
• Collaborating cross-functionally with hardware, systems, and algorithm engineers to define software-hardware interfaces, timing requirements, and safety mechanisms
• Driving verification and validation (V&V) activities, including unit, integration, and system-level testing to ensure reliability and traceability
• Conducting and contributing to risk management activities, including FMEAs, fault detection strategies, and safety classification of software modules
• Mentoring and coaching software engineers, establishing best practices in embedded design, coding standards, documentation, and testing
• Contributing to regulatory documentation and participating in audits and submissions for FDA, MDR, and other global regulatory bodies
• Evaluating emerging technologies (e.g., ultra-low-power MCUs, secure wireless protocols, closed-loop control frameworks) to enhance neurostimulation system capabilities

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Computer Science, or related field
• 10+ years of professional experience in embedded software development, with 5+ years in Class III medical devices or equivalent safety-critical systems
• Expert proficiency in C/C++ for real-time embedded systems (ARM Cortex-M or equivalent microcontrollers)
• Strong understanding of real-time operating systems (RTOS), interrupt-driven design, power management, and low-latency control systems
• Hands-on experience with wireless communication protocols (e.g., BLE, proprietary RF, inductive telemetry) and implant-to-external communication
• Proven experience with software development under IEC 62304, ISO 14971, and FDA 21 CFR 820 design control frameworks
• Demonstrated ability to lead software architecture and mentor teams
• Excellent written and verbal communication skills, especially in regulated design documentation

Preferred Qualifications

• Experience with implantable neurostimulators, deep brain stimulation (DBS), spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), or closed-loop neuromodulation systems
• Familiarity with neural signal processing, ADC/DAC design, and stimulation control
• Experience with MATLAB/Python for modeling, test automation, or algorithm prototyping
• Knowledge of cybersecurity standards for medical devices (FDA premarket guidance, ISO/IEC 81001-5-1)
• Experience with requirements management and traceability tools
• Experience with version control (e.g., Git), requirement management (e.g., DOORS, Jama), and issue tracking tools (e.g., Jira)
• Experience with secure boot, cryptography, and OTA firmware update strategies
• Knowledge of software development management techniques
• Advanced degree (M.S. or Ph.D.) in Biomedical Engineering, Electrical Engineering, or Computer Science

Physical and Other Requirements

• This position is located in Plymouth MN.
• This position is a hybrid position with an expectation of roughly 75% in office and 25% remote work.
• This position requires approximately 15% Travel including international travel.