• Interacted with clients to understand their needs and provided regulatory solutions to meet the project scope. • Assisted in implementation of medical device QMS as per ISO 13485:2016 and 21 CFR 820. Conducted thorough gap analysis and provided remediation plans. • Supported in aligning the technical documentation as per harmonized standards namely, ISO 14971, IEC 62304 and IEC 62366.• Helped medical device start-ups to develop strategies for obtaining medical device regulatory approvals in countries like India and USA. • Provided trainings on medical device regulations (EU MDR and US FDA) and implemented QMS as per ISO 13485 & 21 CFR 820. • Liaised with multiple cross functional teams and successfully handled the projects. • Reviewed the technical documents, labelling & QMS (ISO 13485) and delivered the detailed gap analysis reports. • Worked with the clients in successfully managing change management, nonconformities & complaints and trained the client’s staff on roles and responsibilities of Management Representative.• Reviewed Design History Files and Technical Files of clients for conformance to applicable requirements.• Conducted internal quality audits• Assisted in compilation of CIP in compliance with the Good Clinical Practice (GCP) and trained the Site staff on ISO 14155 and ICH GCP.• Planning enrollment timelines in clinical studies by coordinating with the PIs & provided technical support to the PI on the medical devices being tested.• Provided design and technical insights to the Sponsor’s R&D team & involved in the discussions with KOL’s to analyze the end points pertinent to safety and efficacy of the device.• Submitted clinical trial applications, interacted with regulatory authorities and ECs.• Supported in classification of AEs, DDs, reporting of SAEs, supported in data analysis, trained staff on eCRF and helped in compilation of Clinical Investigation Report

Developed 3D designs of innovative and prospective ideas including applicators for different surgical applicationsParticipated in animal studies along with physicians as part of Design Validation testing for new productsWorked on developing and executing test protocols for new products for Design Verification Testing and Design Validation Testing Performed thorough impact analysis for a Design and Process change projectsPerformed reliability testing for class II productsWorked with suppliers and contract manufacturers in meeting the project deadlines and managing the activities as per planned schedulePerformed Failure Mode Effective Analysis ans Clinical Hazard Analysis for new products

Developed a non linear circuit based model for Brachiocephalic and Radiocephalic fistula vascular access geometries.Developed a flow chart representing various factors affecting the thrombosis formation in End Stage Renal Disease patients.Performed analysis on the factors affecting the failure of arteriovenous fistula.

Implemented the spirometry algorithms on 20,726 patient data and analyzed the results which showed significant variation in the parameters with the numerical integration method used.Worked with an interdisciplinary team to record the impedance cardiography measurements on different chest locations.Assisted in developing a mechanism for feeding milk directly to baby rat’s stomach with minimal damage to the baby rat and decreased the baby rat’s mortality rate by 20%.Mentored a team of five high school students in the Engineering Summer Program in designing prosthetic hand for physically challenged.