– 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.

– 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.

– 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.

– 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.