Lead Engineer, Mechanical
Core
Lead mechanical design and development of complex medical devices, sub-assemblies, and components, ensuring regulatory compliance and optimizing for performance and manufacturability.
Role type
Lead Mechanical Engineer (Medical Devices)
Builds
Medical devices, sub-assemblies, and components
Domain
Medical technology / Mechanical engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design, FEA/CFD analysis, CAD (SolidWorks, Creo, NX), simulation tools (Ansys, Abaqus), medical device regulations (ISO 13485, FDA 21 CFR Part 820), manufacturing processes (injection molding, machining, additive manufacturing), design reviews, risk assessments, FMEA
Preferred skills
Master's degree in Mechanical Engineering
Technologies
SolidWorks, Creo, NX, Ansys, Abaqus
Responsibilities
Lead mechanical design and development of complex medical devices; Conduct advanced engineering analysis (FEA, CFD) to optimize designs; Collaborate cross-functionally with electrical, software, systems, and manufacturing teams; Develop and execute verification and validation test plans; Execute design reviews, risk assessments, and FMEA processes; Identify and evaluate new technologies, materials, and manufacturing processes; Maintain accurate and detailed design documentation including CAD models and technical reports.
Seniority
Lead, hands-on IC with management responsibilities