• Authored comprehensive risk analysis document for robotic surgical system, ensuring compliance with industry safety standards ISO 14971

• Developed statistical rationale and methodologies for reliability testing of reusable robotic hardware components, ensuring product robustness.

• Prototyped test fixtures using SolidWorks, optimizing testing efficency

• Authored and maintained system architecture document and system requirements document

• Led, organized and performed clinical validation with surgeons on cadevaric specimens

• Developed, wrote, and executed system-level Verification and Validation (V&V) protocols, and reports for active orthopedic surgical robots,

• Performed high-precision laser scanning and 3D accuracy analysis using Geomagic software to validate design specifications and ensure product quality.

• Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, and evaluate compatibility of system components in clinical workflow scenarios

• Research regulatory standards such as IEC 60601, and FDA/EU guidance documents to ensure coverage and compliance of medical devices

• Modeling complex systems using Model Based System Engineering (MBSE) Methods

• Work with clinical users of medical technology to evaluate usability of devices

• Design and develop system requirements, documentation, and aid in the implementation and integration of system features for complex medical devices such as cardiomonitoring and tissue oxygenation optical monitoring devices.

• Support integration of software, hardware, and algorithm features through test development and execution

• Test fixture development