Job Description
Responsibilities
Translate clinical and user requirements – including clinician feedback , diagnostic imaging (e.g., ultrasound), and biomechanics – into personalized device design methodologies and functional prototypes.
Develop and refine 3D CAD models , design heuristics, and tools to guide shape selection, parameterization , and manufacturable design , incorporating industrial design principles.
Lead device testing, evaluations, and iterative improvements based on anatomical function, clinical studies, and regulatory feedback.
Conduct physical testing (compression, bending, cyclic loads), FEA and/or mathematical modeling, to optimize device performance.
Maintain Design History Files (DHF) , perform risk analyses (FMEA) , and ensure compliance with ISO 13485 , IEC 60601/62366 (safety and usability eng...