Senior Mechanical Design Engineer

We are a commercial‑stage NeuroTech 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 Senior Mechanical Design Engineer. This position will help bring manufacturing processes in‑house, lead mechanical design, testing, and materials analysis.This is a true player‑coach role. The ideal candidate has deep electro‑mechanical product development experience, strong SolidWorks and GD&T capabilities, experience working within a regulated quality management system, and the ability to manage external contractors, design firms, machine shops, suppliers, and manufacturing partners.This position is based in our office near UCLA.ResponsibilitiesServe as the primary mechanical engineering owner for robotic and non‑robotic ultrasound products.Lead mechanical design activities across the full product development lifecycle, from concept generation through design verification, manufacturing transfer, and sustaining engineering.Design complex mechanisms, enclosures, structural supports, fixtures, tooling, and sub‑assemblies for electro‑mechanical medical devices and capital equipment.Develop detailed 3D CAD models and assemblies in SolidWorks.Create and maintain production‑quality drawing packages using appropriate GD&T in accordance with ASME Y14.5.Perform and document tolerance analyses, including statistical tolerance analysis where appropriate.Design, build, source, integrate, and test prototypes, proof‑of‑concept systems, engineering builds, test fixtures, and manufacturing fixtures.Create mechanical design documentation in support of design controls, including design inputs, design outputs, design reviews, verification plans, test protocols, reports, and traceability.Support risk management activities, including DFMEA, hazard analysis inputs, design risk assessments, and mitigation verification.Design for manufacturability, assembly, reliability, serviceability, and scalability.Lead mechanical design reviews and ensure design decisions are documented, justified, and aligned with product requirements and regulatory expectations.Support environmental, safety, and reliability testing, including testing related to IEC 60601, MIL‑STD‑810, transportation, cleaning, durability, and other applicable standards.Partner with systems, electrical, software, clinical, quality, regulatory, and manufacturing stakeholders to define requirements, resolve technical issues, and deliver integrated product solutions.Manage mechanical engineering contractors, consultants, contract design firms, machine shops, suppliers, and manufacturing partners.Scope outsourced mechanical design work, review contractor deliverables, provide technical direction, and ensure work meets NeuraSignal's quality, schedule, and documentation expectations.Source manufacturers and suppliers for mechanical components, tooling, fixtures, and assemblies.Skills and ExperienceBS in Mechanical Engineering or a related engineering discipline.8+ years of mechanical engineering experience developing electro‑mechanical products.Demonstrated experience owning mechanical design for complex assemblies, mechanisms, fixtures, tooling, and production‑intent hardware.Strong hands‑on engineering capability, including CAD, prototyping, troubleshooting, test fixture design, manufacturing fixture design, and build support.Advanced SolidWorks experience, including complex assemblies, detailed drawings, configuration management, and design for release.Strong working knowledge of GD&T and experience creating professional, production‑ready drawing packages.Experience performing tolerance analysis and applying design‑for‑manufacturing and design‑for‑assembly principles.Experience working in a regulated product development environment with a formal QMS.Experience creating and maintaining design documentation appropriate for regulated development, including requirements, specifications, verification protocols, reports, drawings, BOMs, and design review records.Experience supporting design transfer to manufacturing, including fixture development, inspection planning, assembly documentation, and supplier qualification.Experience managing external contractors, engineering consultants, contract design firms, machine shops, or manufacturing suppliers.Ability to operate effectively as the sole internal mechanical engineer while leveraging external resources as needed.Strong technical judgment and ability to balance speed, quality, manufacturability, cost, risk, and regulatory requirements.Excellent communication, collaboration, documentation, and cross‑functional leadership skills.Ability to work in a fast‑paced startup environment with evolving requirements and limited infrastructure.Preferred Skills and ExperienceExperience developing FDA‑regulated or CE‑marked medical devices.Experience working within an ISO 13485, FDA 21 CFR Part 820, or equivalent regulated quality system.Experience with robotic systems, capital equipment, ultrasound systems, patient‑contacting devices, or clinical workflow‑driven hardware.Experience with IEC 60601 testing, medical electrical equipment safety, environmental testing, cleaning/disinfection requirements, and reliability testing.Experience designing injection molded, machined, sheet metal, 3D‑printed, and cast components.Experience with supplier qualification, first article inspection, incoming inspection, and manufacturing process validation.Experience with SolidWorks PDM, Arena, Agile, MasterControl, Greenlight Guru, or similar PLM/QMS/document control systems.Prior experience as a technical lead, principal engineer, mechanical engineering manager, or sole mechanical engineering owner in an early‑stage company.Graduate degree in Mechanical Engineering or a related technical discipline.#J-18808-Ljbffr