# Ravi Shankar > Principal Quality Engineer @ Confluent Medical Technologies | Quality Assurance, Engineering Location: Fremont, California, United States Profile: https://flows.cv/ravishankar With over 15 years in medical device quality assurance, I currently serve as Principal Quality Engineer at Confluent Medical Technologies, where I specialize in risk management, design verification, and post-market surveillance for Class II and III devices. My mission is to ensure product reliability and regulatory compliance in line with ISO 13485 and 21 CFR 820 standards, contributing to the successful development and launch of sophisticated medical solutions. At Bigfoot Biomedical, I led cross-functional teams through 510K approvals, post-market failure investigations, and robust CAPA processes, elevating product quality and user safety. My expertise spans interconnected hardware, mobile apps, and web services, supported by advanced testing protocols and metrics development. Known for fostering collaboration and precision, I empower teams to achieve operational excellence in fast-paced environments. ## Work Experience ### Principal Quality Engineer @ Confluent Medical Technologies Jan 2023 – Present ### Director, Design Assurance @ Bigfoot Biomedical Jan 2019 – Jan 2023 – Led Design verification activities for Bigfoot Unity System and obtained successful 510K approval. – Developed process and led a cross-functional team for failure investigation of complaints after commercial launch. – Created metrics for visibility to senior leadership on post-market surveillance activities. – Mentor and train cross-functional engineers on robust CAPA and Failure investigation techniques. – Managed a team of 5 Design Assurance engineers to support major and minor product releases. – Team player and collaborated with cross functional team members across all levels within the organization. ### Sr Manager Design Assurance @ Bigfoot Biomedical Jan 2017 – Jan 2019 | Milpitas, CA – Led projects for next-generation products to the launch phase by managing cross-functional team members. – Developed new reliability tests in addition to standard tests to reduce use case errors during development. – Drafted test protocols and reports for Design verification testing (DVT) complying with IEC and ISO standards. – Served as a team member on both new product development projects and the post-market surveillance team. – Managed and trained R&D technicians and engineers in the test development process. – Developed automated test fixtures to simulate user actions to simulate real use case scenarios. ### Design Assurance Manager @ Bigfoot Biomedical Jan 2017 – Jan 2017 – Led projects for next-generation products to the launch phase by managing cross-functional team members. – Developed new reliability tests in addition to standard tests to reduce use case errors during development. – Drafted test protocols and reports for Design verification testing (DVT) complying with IEC and ISO standards. – Served as a team member on both new product development projects and the post-market surveillance team. – Managed and trained R&D technicians and engineers in the test development process. – Developed automated test fixtures to simulate user actions to simulate real use case scenarios. ### Senior Design Assurance Engineer @ Bigfoot Biomedical Jan 2015 – Jan 2017 | Milpitas, CA – Developed system level test methods and protocols for interconnected Automated Insulin Delivery System. – Performed verification testing for both insulin pens and insulin pumps connected to mobile apps and web services. – Participated in FDA and TUV audits as a system level technical resource. ### Senior Design Assurance Engineer @ Asante Solutions Jan 2013 – Jan 2015 | Milpitas, CA • Lead projects for next-generation products to launch phase by managing cross-functional team members • Developed new test methods and protocols in addition to standard tests that reduced customer complaints in the field by 40% • Developed requirements, test protocols and reports for Design verification testing (DVT) complying IEC and ISO standards • Participated in FDA and TUV audits as a system level technical resource • Performed dFMEA, Hazard analysis, Risk evaluation and generated trace matrix for Class II medical device • Served as team member on new product development project teams and post market surveillance team • Managed and trained R&D technicians and engineers in test development process ### Systems Test / R&D Engineer @ Asante Solutions Jan 2007 – Jan 2013 - Developed concepts and ideas into functional parts for the development of Class II device - Partnered with cross-functional teams in the product development cycle - Practiced Good Laboratory Practices (GLP), record keeping, and documentation (DCO, NCR, and CAPA) in order to comply with internal standards and external regulatory requirements - Built basic LabVIEW virtual instruments program to communicate with nano gauge and precision instruments - Familiarity in manufacturing processes such as injection molding and sheet metal fabrication - Utilized statistical techniques to understand process variables and their impact on outcomes with an emphasis on data based decision making - Experience in coordinating with vendors and outside testing facilities for product development ## Education ### Master's degree in Mechanical Engineering University of Cincinnati ### B.Tech in Mechanical Engineering National Institute of Technology Kurukshetra ## Contact & Social - LinkedIn: https://linkedin.com/in/ravirr --- Source: https://flows.cv/ravishankar JSON Resume: https://flows.cv/ravishankar/resume.json Last updated: 2026-04-13