Toro Neurovascular develops innovative catheter technologies that enable physicians to address unmet clinical needs in acute ischemic stroke treatment. Our mission is to improve patient outcomes in the neurovascular space.

• Responsible as Management Representative under ISO 13485:2016 and as Person Responsible for Regulatory Compliance under European Medical Device Regulation 2017/745.• Led transition to EU MDR 2017/745 compliance by performing gap analysis, updating Quality System requirements, and creating Periodic Safety Update Reports (PSUR)• Head design Engineer and project manager for design and development of extensive catheter portfolio, including various diameters, lengths, and varying stiffness and construction profiles to broadly address user needs for general neurovascular catheter applications – succeeded in achieving CE Mark approval o Designed, 3D modeled, dimensioned, and created drawings for all device and packaging components o Determined product specifications and testing requirements, developed test methods and sampling/statistical requirements, and directed qualification test flows o Managed and executed supplier qualifications for 11 different suppliers, including performing supplier audits and drafting/negotiating supplier quality agreements o Created product risk documentation including FMEAs and risk management reports• Created infrastructure within QMS to enable remote work and 21 CFR Part 11 compliant approval of records during COVID-19 pandemic• Implementation of regular Material Review Board meetings to improve management and accountability of nonconformance and CAPA closures• Developed bioburden monitoring system and procedures for compliance to ISO 11737-1:2019• Ran Supplier Management system including periodic Quality System Audits of critical suppliers• Lead Facilitator for internal and external audits• Created system and methodology for periodic review of External Standards and Regulations, including gap analysis and implementation of updated revisions and requirements to existing projects and systems• Supported site qualification and manufacturing transfer for company move to a new facility

• Strategically planned six-month restructure of Operations Quality Engineering group, including resource needs, hiring strategy, reporting structure, and team member responsibilities and allocations• Provided leadership and development for teams of up to eight Quality Engineers and Technicians to resolve issues, reduce nonconformances, stabilize production, and improve yields for stent manufacturing• Planned and directed site-wide Repack Validation

• Validated clean room following construction of additional space• Performed software validations of automated visual measurement system and laser welding recipes• Provide leadership and development for a team of five Quality Engineers and a Quality Technician supporting manufacturing of all guidewire, catheter, balloon, infusion, and Atherectomy products• Interface directly with external auditors during inspections and provide responses as internal SME• Provide training and alignment for the roll out of DMAIC methodology as standardized problem solving technique within Operations Quality and Manufacturing Engineering groups

• Created test methods to detect counts of small and large particulate generated during simulated use of Peripheral Infusion Catheters• Led supplier qualification for the manufacturing transfer of thirty two existing components to new suppliers, including component-level risk analysis, distribution and capability analysis, and correlation studies• Led root cause investigations for various product and equipment nonconformities, utilizing tools such as Ishikawa Diagram, 5 Whys methodology, 6Ms, and Contradiction Matrix• Hands-on troubleshooting of various manufacturing equipment and processes including laser welding and cutting, electro-polishing, etching and passivation, braiding, coil winding, heat treating, laminate reflow, dip coating, crucible coating, injection molding, and pouch sealing• Analyzed ongoing statistical process control data, investigating any out-of-control signals and correcting the process to ensure outgoing product quality

• Designed fixture using SolidWorks to ensure compliant receiving inspection of Luer tapers per ISO 594-1• Constructed gage R&R and correlation studies to understand sources of variation in dimensional inspection• Corresponded with Suppliers to communicate nonconformities, lead root cause investigations, and aid in implementation of corrective and preventative actions

• Designed and built an anatomical spine model to test company’s delivery sheath against other designs.• Developed an improved delivery sheath geometry to allow for increased product delivery success rate. Used anatomical spine model to test and validate this design.• Development of machining and injection molding processes for user-attached radiopaque markers to differentiate between delivery leads while implanted in patient• Designed, 3-D printed, and machined to create a fixture and test method capable of comparing the abrasion resistance of two polymer coatings on small diameter electrical leads

• Set up orientation events for incoming students• Led groups of incoming students around orientation• Sat on a panel of students answering questionsfor incoming freshmen