Director of System Engineering

Responsibilities

• Own engineering updates for NeuraSignal’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 NeuraSignal’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.

Qualifications

• 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, capital equipment, diagnostic systems, or similarly complex technical products.
• Experience leading product updates for released or production-intent products.
• Demonstrated ability to work across mechanical, electrical, software, test, and systems engineering domains.
• Hands-on technical strength in at least one core engineering discipline, with enough breadth to lead and challenge work across multiple disciplines.
• Experience with software-enabled electro-mechanical products.
• Experience working in a regulated product development environment with a formal QMS.
• Strong understanding of design controls, change control, risk management, verification, validation, traceability, and design documentation.
• Experience leading root cause analysis and corrective actions for complex product, manufacturing, or field issues.
• Experience creating or reviewing requirements, specifications, test protocols, test reports, engineering change orders, risk documentation, and design review materials.
• Experience managing contractors, consultants, external engineering firms, test labs, suppliers, or manufacturing partners.
• Ability to make balanced technical decisions involving safety, performance, usability, reliability, cost, manufacturability, schedule, regulatory impact, and customer need.
• Strong project leadership skills, including planning, prioritization, resource coordination, risk management, and executive communication.
• Excellent written and verbal communication skills.
• Ability to operate effectively in a startup or small-company environment where priorities evolve and infrastructure is still being built.

Preferred Qualifications

• Experience with FDA-regulated or CE-marked medical devices.
• Experience with diagnostic ultrasound, transcranial Doppler, vascular diagnostics, neuromonitoring, robotic medical devices, image-guided systems, or clinical capital equipment.
• Experience with both manual and automated/robotic product configurations.
• Familiarity with applicable medical device standards such as IEC 60601, IEC 62304, ISO 14971, IEC 62366, and relevant EMC, electrical safety, usability, cybersecurity, and software lifecycle expectations.
• Experience with FDA QMSR, ISO 13485, design history files, technical files, and post-market surveillance processes.
• Experience with embedded software, firmware, real-time systems, motor control, sensors, signal processing, imaging systems, or ultrasound-related hardware.
• Experience with manufacturing test systems, service diagnostics, calibration, production fixtures, field service workflows, and reliability improvement.
• Experience with component obsolescence, supplier changes, alternate part qualification, and design changes for manufacturability or cost reduction.
• Experience with Agile/Jira, PLM systems, electronic document control, requirements management tools, SolidWorks, Altium, Git-based workflows, or similar engineering tools.
• Prior experience as a product line engineering leader, systems engineering lead, sustaining engineering manager, R&D manager, or principal engineer for a complex medical device platform.