Adraxe: Principal Systems Engineer

Job Title: Principal Systems Engineer

Company: Adraxe

Job Type: Full-Time

Location: Plymouth, MN (Hybrid)

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
We are seeking a highly experienced and technically driven Principal Systems Engineer to lead systems engineering for a closed-loop epilepsy therapy system, with primary emphasis on neural interface performance, end-to-end system integration, full-stack data flow, and optimization of seizure detection algorithms within a regulated (PMA) development framework. The system includes an active implantable medical device (AIMD), custom external instruments, clinician and patient applications, and a secure cloud platform.

The ideal candidate is a systems engineer who is strongest at the intersection of neural signals + real world data + integrated system behavior who can reason from electrode physics to algorithm metrics to telemetry and cloud pipelines, and knows how to turn that into testable requirements and credible verification evidence. The ideal candidate;

• Has owned or heavily influenced signal chain and algorithm performance in embedded, constrained systems and is comfortable building evaluation frameworks and test plans that reflect reality, not ideal lab conditions.
• Understands that “algorithm performance” isn’t just a model score—it’s latency, robustness, power, reliability, data quality, and user workflow.
• Can lead cross-functional teams through integration complexity with discipline appropriate for PMA.
  

This position will report directly to the VP of Engineering, will have significant input into Adraxe strategy and planning, and will collaborate closely with all technical disciplines at Adraxe.

What you'll do
Systems Architecture and Technical Leadership

• Define and maintain the system architecture spanning implant, external instruments, clinician/patient applications, and cloud services.
• Lead trade studies (power, latency, telemetry, sensing/stimulation performance, reliability, safety, cybersecurity) and drive decisions with cross-functional alignment.
• Establish and manage interfaces (electrical, RF/telemetry, APIs, data models, workflow integrations) and ensure compatibility across subsystems.
• Guide development of closed-loop control concepts (sensing → detection/classification → therapy delivery → adaptation), including system-level performance metrics and constraints.

Neural Interface & Signal Chain Ownership

• Develop deep system-level understanding of the neural interface (electrode-tissue interface, sensing modalities, impedance behavior, artifact sources, saturation, noise, drift) and how it impacts detection and therapy performance.
• Define and manage requirements for the signal chain (front-end analog, ADC, filtering, sampling, dynamic range, stimulation artifact handling, telemetry constraints) and ensure traceability to detection performance and safety.
• Partner with hardware, firmware, and clinical teams to characterize signal quality across populations and conditions (movement, sleep, medication changes, electrode maturation).

Seizure Detection Algorithm Performance & Optimization

• Translate clinical needs into measurable algorithm performance metrics (e.g., sensitivity, false alarm rate, latency to detection, time-in-warning, robustness to artifacts) and establish acceptance criteria.
• Drive system-level optimization across algorithm + firmware + data pipeline to meet performance targets under real device constraints (compute, memory, power, latency).
• Lead closed-loop performance analyses that connect sensing → detection → therapy behavior, including edge cases and failure modes.
• Coordinate creation of curated datasets, labeling strategies, ground-truth definitions, and evaluation protocols (including subgroup and scenario performance).

End-to-End Data Flow & Observability (Implant → External → Apps → Cloud)

• Define and validate the complete system data flow: on-device data generation, event markers, compression/packetization, telemetry, external device handling, app storage/display, cloud ingestion, processing, and analytics.
• Ensure data integrity across the lifecycle: time synchronization, identity mapping, provenance, audit trails, retention, and traceability required for regulated evidence.
• Specify and validate observability features: logging, metrics, error reporting, trace IDs, and tools to support troubleshooting, clinical workflows, and post-market surveillance.

System Integration & Test Leadership (PMA-Grade Evidence)

• Own the integrated system test strategy with emphasis on realistic, high-value integration coverage (HIL/SIL, simulated physiology, induced artifacts, telemetry stress, app/cloud failure modes).
• Define system-level test methods and rigs to validate sensing and detection performance under representative conditions (including stimulation artifact conditions if applicable).
• Drive integration readiness criteria, defect triage workflows, and release gating for end-to-end functionality.
• Ensure traceability from user needs and hazards to verification evidence across the integrated system.

Safety, Risk, and Performance Boundaries for Closed-Loop Operation

• Lead identification of hazards and risk controls related to detection performance, therapy timing, and data integrity (e.g., missed detection, false positives, telemetry dropouts, timebase drift, data corruption).
• Define safe bounds and fallback behaviors (therapy limits, safe modes, detection confidence gating, watchdogs) and verify they work across system states and failures.

Verification, Validation, and Test Strategy

• Lead design verification testing (DVT) and verification planning to ensure compliance with medical device standards and safety requirements.
• Ensure designs meet relevant standards (e.g., IEC 60601, ISO 14708, ISO 14971, EMI/EMC compliance).
• Define end-to-end system verification and validation strategy across implant + external + applications + cloud, including integration and system testing.
• Develop test environments (benchtop rigs, simulators, HIL/SIL as appropriate, clinical workflow simulations)
• Data-driven verification of sensing/detection/therapy performance (as applicable)
• Drive design reviews, ensure readiness for formal V&V, and support PMA documentation and inspection readiness.

Cross-Functional Leadership and Mentorship

• Lead technical alignment across firmware, hardware, algorithms, app engineering, cloud, clinical, quality, regulatory, and manufacturing.
• Mentor systems engineers and establish best practices for systems engineering rigor, documentation quality, and integration readiness.
• Communicate clearly with stakeholders, translating complex technical tradeoffs into decision-ready options and documented outcomes.

Qualifications
Minimum Qualifications are:

• B.S. in Systems, Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field.
• 10+ years (or equivalent) experience in systems engineering for complex electromechanical and software-intensive products; medical device experience strongly preferred.
• Demonstrated experience developing implantable and/or active therapeutic devices (e.g., neuromodulation, cardiac rhythm management, or similar).
• Experience with implantable sensing modalities and neural signals (e.g., iEEG/ECoG/SEEG or related), including artifact sources and long-term recording challenges.

Strong command of:

• Requirements development, decomposition, and traceability
• System architecture and interface definition (ICDs)
• System integration and V&V planning and execution for distributed systems
• Risk management and safety engineering in regulated contexts
• Proven ability to lead through influence across multi-disciplinary teams and drive cross-functional execution.
• Strong written and verbal communication skills, including the ability to produce clear, inspection-ready technical documentation.

Preferred Qualifications

• M.S. or Ph.D. in Electrical Engineering, Biomedical Engineering, or related field.
• Experience supporting PMA development (design controls, DHF evidence, traceability, and system V&V evidence packages).
• Experience with seizure detection/classification and/or robust biosignal detection methods in real-world settings.
• Experience designing and validating end-to-end data pipelines for regulated products (time sync, provenance, auditability, retention, access control).
• Strong background in system integration testing for distributed systems (embedded + apps + cloud), including SIL/HIL, simulation, and test automation.
• Working knowledge of cybersecurity engineering for connected medical systems (threat modeling, encryption, key management, vulnerability management).

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.