Director of System Engineering

We are a commercial-stage Neuro Tech startup backed by a billion-dollar family office. Our clinically validated suite of software and hardware products enables the standardized collection of transcranial Doppler measurements, which was previously possible only with highly specialized sonographers.

We have partnered with our CEO and CTO to hire our Director of System Engineering. This will be a player‑coach who will own the diagnostic platform, guiding the team through product sustainment and into future next‑gen development.

This person will be responsible for leading mechanical, electrical, software, test, manufacturing, service, and documentation updates to released or near‑released diagnostic products.

This position can be a hybrid work schedule for the right candidate.

• Own engineering updates for Neura Signal’s diagnostic TCD product line, including manual and robotic product configurations.
• Serve as the technical owner for sustaining engineering, lifecycle engineering, and post‑release product improvements.
• Lead cross‑functional execution of mechanical, electrical, software, firmware, systems, test, manufacturing, and service‑related product changes.
• Translate field feedback, manufacturing issues, service data, complaints, nonconformances, CAPAs, supplier changes, obsolescence risks, and product roadmap needs into clear engineering change plans.
• Prioritize and manage the diagnostic product engineering backlog in partnership with Product, Quality, Regulatory, Manufacturing, Service, Supply Chain, and company leadership.
• Lead design updates from problem definition through root cause analysis, technical solution development, verification, validation, documentation, and release.
• Own technical impact assessments for proposed changes, including product performance, safety, usability, reliability, manufacturability, serviceability, cost, regulatory, and risk‑management implications.
• Lead system‑level troubleshooting of complex electro‑mechanical and software‑enabled medical device issues.
• Review and guide mechanical design changes, including CAD, drawings, tolerance considerations, fixtures, enclosures, assemblies, mechanisms, and manufacturability.
• Review and guide electrical design changes, including component selection, obsolescence management, PCB‑related updates, cabling, sensors, power, grounding, EMI/EMC considerations, and system integration.
• Review and guide software and firmware updates, including requirements, architecture implications, defect resolution, user interface changes, cybersecurity considerations, release planning, and verification strategy.
• Own or oversee requirements updates, design inputs, design outputs, design reviews, risk documentation, verification protocols, test reports, traceability, and engineering change documentation.
• Ensure product updates are executed in compliance with Neura Signal’s QMS and applicable medical device design control expectations.
• Lead or support risk management activities, including hazard analysis updates, FMEA updates, risk‑benefit considerations, mitigation verification, and post‑market risk feedback.
• Develop and maintain verification strategies for product updates, including bench testing, system testing, regression testing, fixture‑based testing, reliability testing, and manufacturing/service test methods.
• Lead the development and improvement of test fixtures, manufacturing fixtures, service tools, calibration methods, troubleshooting procedures, and production documentation.
• Manage external contractors, consultants, design firms, software partners, electrical engineering resources, mechanical engineering resources, test labs, and suppliers.
• Scope outsourced engineering work, define deliverables, review technical outputs, manage schedules, and ensure contractor work meets company quality and documentation standards.
• Manage and mentor a small internal team.

• BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Systems Engineering, Software Engineering, or a related technical discipline.
• 10+ years of engineering experience in medical devices, regulated electro‑mechanical products, robotics,…