Sr Engineer Design
Core
Lead complex product design initiatives for medical devices, translating user needs into design specifications and ensuring regulatory compliance.
Role type
Senior Design Engineer (Medical Devices)
Builds
Medical device prototypes, CAD models, and technical documentation
Domain
Medical Devices / Mechanical & Electrical Engineering
Deliverable
production ML models | product features
Required skills
SolidWorks, 3D CAD, design for manufacturability, risk management (FMEA), regulatory documentation (DHF, DMR), injection molding, machining, assembly techniques
Preferred skills
Certified Solidworks Professional, Class II medical device launch experience, intellectual property strategy
Technologies
SolidWorks, CAD software
Responsibilities
Develop CAD models and prototypes meeting regulatory requirements; guide cross-functional collaboration to define user needs; drive design transfer from R&D to manufacturing; mentor junior engineers; integrate human factors and user-centered design; manage multiple projects to meet milestones; evaluate existing products through root cause analysis and risk assessments.
Seniority
Senior, hands-on IC with mentorship