Senior Mechanical Design Engineer

Responsibilities

• Serve 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.
• 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.

Requirements

• BS 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.

Skills and Experience

• Experience 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.