Manages end to end clinical investigation studies, Post marketstudies, Clinical validation studies liaising with multiplestakeholders.

Lead Biomedical Engineer in Medical device research and development for ~ 4 years providing product usability, evaluation and support to product development teams, including the analysis and investigation of applications/systems.• Ownership of plan and conduct formative and summative usability evaluations and analyze findings of those evaluations for purposes of design recommendations. This includes writing Usability protocol Usability protocol and maintaining the Usability Engineering File for Class II, Class III medical devices as per IEC 62366:2007 standard. Clear understanding on industry requirements and guidelines for human factors engineering of medical technology. Responsible for developing clinical protocols for Clinical Evaluation and Validation of the medical devices as per the company SOPs and guidelines as per the applicable regulatory standards. Responsible for verification and validation protocols for in-house product development testing. Corporate trainer for more than 6 years in Medical device industry. Hands on experience on ISO 14971:2012 Medical Devices – “Application of Risk Management to Medical Devices”. Involved in Fault tree analysis, and failure analysis. Hands on experience on ISO 13485:2003 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes and good exposure to 21CFR 820. Responsible for the preparation of Product Manual, User Guide, technical publications etc for the new products. Responsible for the preparation, review and release of product and accessories labels and marking for different markets as per ISO 15223-1:2012 and applicable standards. Involved in maintaining the System V&V Test Traceability Matrix (TTM). Hands on experience with the medical devices like Automatic External defibrillator, Patient Monitors, Pulse oximeter, Vascular devices, ECG machines, TMT & Holter, ECG recorder etc.

• Responsible for the clinical support of ElectroPhysiologist during electrophysiology procedure using conventional mapping and 3D mapping.• Preparing case studies of attended cases and presenting in the FCE forum.• Conducting evaluation programs for different catheters in hospitals.• Conducting campaigns & promotions on EP devices every month• Conducting & coordinating workshops in major hospitals of India with foreign KOLs (Key Opinion Leaders – primarily doctors) .• Conducting training for distributor staff and cathlab technicians

• Pace maker implant support in cathlabs • Conducting Market development activities, running campaigns, meeting doctors and generating sales.• Arranging training sessions to distributor staff and cathlab technicians• Attending trainings and internal certification to keep updated to latest developments on cardiac devices like Pacemakers, Cardiac recording system, Implantable defibrillators, and Cardiac resynchronization therapy.