Jaime Espinola

• Wrote and executed process validation studies • Developed test methods to evaluate product • Designed and executed DOEs with vendors to optimize designs for manufacturability (DFM) and to reduce process variation • Designed and modeled a variety of test fixtures • Planned and executed Process Characterization for manufacturing processes • Developed and wrote manufacturing instructions Key Project: • Supported integration and product update of pulmonary embolism ultrasonic catheter o Developed and validated test methods for added verifications o Executed DOEs to optimize tensile strength of components o Created prototypes to evaluate test methods o Wrote and released pFMEA for device

• Served as the R&D Technical lead, providing solutions to design issues • Designed and executed design verification, design validation, and shelf life testing • Developed test methods to evaluate product • Validated attribute and variable test methods for use in DV and Vendor inspections • Supported 510k/PMA submissions for new and updated products • Led and supported VIP projects saving the organization ~$400k Key Project: • Owned CAPA for suture cutting during pelvic floor repairs which successfully implemented a solution after 2 prior, unsuccessful CAPAs. o Drove root cause investigation, implementing changes to vendor’s metal injection molding process o Designed innovative measurement technique to evaluate device performance without bench top testing o Constructed and executed a DOE to optimize the vendor’s process for deburring components o Evaluated lot-to-lot component variation to set appropriate tolerance range for drawing dimensions o Led DVAL cadaver lab evaluate user impact of the design change o Supported 510k submission for updated design