Blackrock Neurotech · 2 months ago
Adraxe: Principal Firmware Engineer
Plymouth, MN
Full-time
Hybrid
Lead/Staff
10+ years expAdraxe Corporation is an innovative medical device startup focused on developing breakthrough neuromodulation solutions for epilepsy. The Principal Firmware Engineer will lead the design and development of safety-critical firmware for advanced neurostimulator systems, collaborating with cross-functional teams to deliver compliant software solutions.
Medical DeviceNeuroscience
Responsibilities
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
Qualification
Required
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
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
Company
Blackrock Neurotech
Blackrock Neurotech is a team of the world’s leading engineers, neuroscientists, and visionaries.
51-200 employees
H1B Sponsorship
Blackrock Neurotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (5)
2023 (7)
2022 (6)
2021 (1)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$12.37M2024-05-06Series Unknown· $12.37M
Leadership Team
M
Marcus Gerhardt
Co Founder & CEO
Recent News
Business Wire
2025-06-22
2024-05-12
2024-05-12
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