Rishi Vakharia

• Led ISO 13485 audit readiness end to end — owned QMS documentation, prepared and supported both internal and external certification audits, and achieved full compliance with international regulatory standards. • Authored and implemented manufacturing SOPs and Work Instructions for scalp-cooling device production, reducing process errors and strengthening product quality and traceability. • Performed inward quality inspections using sampling methods and maintained full traceability documentation, ensuring incoming components met design and regulatory specifications. • Owned end-to-end procurement and inventory control — negotiated supplier contracts and reduced critical-component purchase costs by 30–40%, while strengthening procurement flow to eliminate production downtime. • Led US market expansion of the EVA scalp-cooling system — drove labeling, packaging redesign, and electrical-system reconfiguration to US power standards, enabling export readiness. • Designed and owned the development of a new scalp-cooling insulation cap delivering 100% cooling coverage across the head, improving therapy uniformity and patient outcomes. • Contributed to the R&D pipeline on ORIS (oral mucositis) and SIRA (limb-cooling for chemotherapy), and successfully launched SIRA into clinical studies at Grace Hospital, Vasai — currently enrolling patients. • Supported cross-functional operations including IT, manufacturing, and supply chain to keep production and product-development workflows running uninterrupted.

• Spearheaded the design, prototyping, and testing of the Tissue Collection Device, leading to a 20% increase in specimen retrieval efficiency. Managed the entire process from concept to manufacturing release, ensuring compliance with cGMP and ISO 13485:2016 guidelines. • Enhanced R&D lab capabilities by purchasing essential prototyping equipment and upgrading existing tools, resulting in a 15% reduction in prototyping time and improved ease of medical device development. • Implemented strategies to improve inspection times and reduce technician strain for incoming part inspections. Utilized data analysis to identify parts that could benefit from advanced inspection technologies, such as the Keyence IM system, significantly increasing part throughput and inspection efficiency.

● Spearheaded the development of advanced electrosurgical systems to improve surgical safety and procedural efficiency; led design control activities including requirements definition, risk analysis (FMEA), and design traceability, while also driving test method development aligned with IEC 60601 standards. ● Authored comprehensive design verification protocols and optimized technical documentation, enhancing regulatory readiness and ensuring alignment with FDA 21 CFR Part 820 and ISO 13485 quality system requirements.

• Collaborated on engineering based innovative design solutions for Vessel Everter and the Beta version of Calexis-Lap, contributing to technological advancements. • Established Quality Management Systems, ensuring industry-standard compliance and seamlessly integrating quality processes. • Developed foundational and controlled documents like Requirements, Quality Manual etc… for the Quality Management System, including policies, procedures, and protocols. • Assisted in gathering testing results during animal studies trials and demo phases of Calexis-Lap, analyzing exceptions/anomalies/variations, brainstorming engineering innovations and designing modifications leading to risk mitigation of the device.

● Undertook design improvements, prototype testing, Verification & Validation, Bill of Materials management & controls. ● Performed Design Verification & Performance Validation testing in Thrombosis, Biopsy and Trans Jugular Intrahepatic Portosystemic Shunt (TIPS) related medical devices for 510(k) pathway. ● Performed calibration and troubleshooting of medical device equipment (digital microscopes involving Inferior Vena Cava Filter, Aspiration Canister). ● Documented the performance features of catheters, dilators, and sheaths from various manufacturers. ● Collaborated with suppliers, graphic designers, and translation agencies to improve operations and reduce costs. ● Documented the Anatomical Mapping of Cardiovascular Systems, and the vasculature dimensions.

● Initiated design enhancements and prototype testing for medical devices related to Thrombosis, Biopsy, and Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures, ensuring compliance with FDA 510(k) regulatory requirements and ISO 13485:2016 and ISO 14971:2019 standards for quality and risk management. ● Designed and fabricated silicone liver tissue analogs to simulate anatomical and mechanical properties for Transjugular Intrahepatic Portosystemic Shunt (TIPS)-related device testing; leveraged prototypes to support clinical demonstrations and engage marketing and clinician stakeholders in the development of user needs and system requirements. ● Conducted Design Verification & Validation Testing on various medical devices, including Inferior Vena Cava Filters, Aspiration Canisters, luer connectors, and catheters, providing data-driven insights to cross-functional teams and ensuring robust product performance. ● Mapped anatomical structures of cardiovascular systems, referenced existing literature to guide product design, enhanced testing accuracy, and supported informed decision-making in the design and development process.

● Created documents for Design Controls, Process Controls, Quality Systems processes defined per 21 CFR Part 820. ● Provided data driven engineering insights to product development team on product performance of medical devices manufacturing competitors. ● Developed protocols, executed benchmark testing, performed data analysis, and authored reports in compliance with procedures and SOPs on luer connectors for PICC, endomyocardial biopsy forceps and PEEK catheters for TIPS.

● Mentored and tutored students in Medical Imaging coursework. Provided feedback and graded assignments, exams, and papers for undergraduate and graduate students. Assisted students in lab work and taught proper equipment handling techniques ● Held regular office hours, offering academic support to students through answering questions, clarifying coursework materials, and providing guidance on assignments and study strategies.

● Mentored and tutored students in Medical Device Design coursework. Provided feedback and graded assignments, exams, and papers for undergraduate and graduate students. Assisted students in lab work and taught proper equipment handling techniques ● Assisted students with design process questions on DFMEA tables, Pugh Matrix, and House of Quality from their coursework-related team projects. ● Held regular office hours, offering academic support to students through answering questions, clarifying coursework materials, and providing guidance on assignments and study strategies.

● Designed biomedical devices like electrosurgical units on Printed Circuit Board using software from Altrium, CAD modeling software on SolidWorks and embedded systems. ● Assembled components and performed non-clinical testing during the development of new launched products ● Guided the production department by providing technical support on the company’s line of products including Electrosurgical, Laparoscopic equipment and Alarm annunciator.

1) Worked under Dr. Rohit Srivastava and Mr. Anurag Meena at Dynasense Technologies Pvt Ltd for Optical Glucometer. 2) This type of medical device has clinic utility to determine the concentration of glucose from a sample of blood of patients who have been diagnosed by diabetes mellitus. 3) This device worked on the principles of electrochemistry to obtain the reading of the concentration of glucose level from samples using the principle of light.

• Maintained & serviced the biomedical equipment by organizing a planned maintenance program and keeping maintenance logs. • Assisted quality assurance engineers in IQ/OQ/PQ activities and validation process. • Provided training to nurses and doctors for using the newly installed medical equipment. • Routine calibration and checkup of the equipment in the hospital especially in ICU’s and operation theaters.

Specialization - Medical Devices BMEN Graduate Scholarship Spring 2022 through Summer 2023