As a R&D Mechanical Engineer within our Mechanical team, you will lead development of mechanical systems and subsystems of our next-generation surgical robot from the early concept to the to a verified product.
Responsabilidades
: R&D & Mechatronic Subsystem Design• Lead the end-to-end design and development of high-precision mechatronic subsystems for surgical robotics, translating clinical and industrial design inputs into simple and robust mechanical solutions.• Execute detailed design work utilizing 3D CAD (Solidworks), finite element analysis (FEA), and worst-case tolerance stack-up analyses
And applying DFM/DFA principles to optimize cost, yield, and assembly efficiency.
• Collaborate within cross-functional R&D teams (Electrical, Software, Systems, and Clinical) to rapidly prototype, validate, and iterate robotic platforms and subsystems.
Verification, Testing & Tooling• Architect, build and document custom mechatronic test benches and automated test fixtures for design verification, fatigue testing, and end-of-line production testing.
• Author and execute verification protocols and reports to prove subsystem performance against medical device.
Requisitos
.Design Transfer & Supply Chain• Support Design Transfer to Contract Manufacturers, by transferring technical knowledge to industrialization teams, reviewing Work Instructions and pFMEAs, and supporting process-specific tool development.• Support mechanical supplier selection and qualification, support root-cause analyses for supplier-related quality issues (NC/CAPA).Medical Device Compliance & Lifecycle• Maintain full compliance with medical device standards (e.g., ISO 13485, IEC 60601-1, ISO 14971) and author compliant Design History File (DHF) documentation.• Plan and execute Engineering Change Requests, ensuring robust risk management and traceability.• Chair formal technical design reviews and present architectural decisions to cross-departmental stakeholders and leadership.RequirementsWork Exp...