-Act as lead engineer and project manager for the development of new cardiovascular and neurovascular catheters, including those used for heart valve replacement and retrieval, steerable diagnostic catheters, neuro-aspiration, and EP mapping catheters-Lead a focused team of engineers, technicians, and assemblers to drive the development forward-Guide and manage a project through the full design control process from ideation to regulatory submission-Communicate directly on a daily and weekly basis with project stakeholders, including internal leadership, sales, and customer representatives on project status, timeline, scope changes, and budget-Track material and labor expenses towards individual projects on a monthly basis for invoicing purposes-Lead efforts for data driven design to optimize performance, including catheter torque response, tensile strength, column strength, flexibility, trackability through tortuous anatomy, corrosion resistance, kink resistance, etc-Set up and maintain pilot lines ranging from quick-turn R&D builds to fully controlled and traceable builds for DV testing and regulatory submission-Facilitate transfer from R&D status through process development and ultimate hand-off to high-volume production-Actively manage and support multiple projects at a time-Work directly with material and servicing vendors to design, size, order, and test materials used for catheter construction and testing-Lead full A3 root cause investigations into design, yield, or catheter performance issues

-Collaborated with other development engineers and technicians to develop catheters, catheter subassemblies, and processes according to customer design, performance, and quality specifications; on time and within budget.-Kept stakeholders, customers, and others informed of project status and/or related issues-Hands-on catheter design, development, and assembly with customers, both internal and external-Wrote, monitored, managed, and reviewed protocols, including verification and validation tests, ECO, SOP's, BOM's, drawings, etc. as required to develop, support, or maintain technical documentation-Coordinated activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification

• Design, build, and test device prototypes for animal studies and new product development.• Coordinate and run various validation testing for products and processes.• Create and perform DOEs to evaluate different materials and designs.• Use SolidWorks to design product components and fixtures for manufacturing and testing.• Communicate with contract manufacturers to set up pilot lines and submit build requests.

• Worked within cross-functional teams to transfer and implement new products into production.• Evaluated time, cost, and material capabilities for incoming manufacturing processes.• Created and updated manufacture-ready digital files for production components.• Designed and created CAD solid models in SolidWorks and Inventor for production tooling and fixtures.• Applied analytical and problem solving skills on a daily basis to increase process efficiency and decrease machine downtime.

• Collected and maintained daily records of project progress. • Communicated daily between project managers, foremen, and vendors on project progress.• Verified project files, specifications, and plans were up to date on a daily basis. • Updated mechanical plans to reflect current design. • Used Excel to adjust manpower schedules and create forecasting timelines.

• Led a team through the design process of a CNC grinder from concept to the construction and testing of a completed prototype. • Communicated design proposals and negotiated options with the industry sponsor.• Created mechanical drawings, Bill of Materials information, and other documentation for prototype release. • Evaluated prototype machine and designs for refinement through assembly and testing. • Procured materials and tools for prototype construction, including 3D printed components.

• Created an Excel spreadsheet that used Macros, advanced if-statements, and advanced formulas to create factory floor configurations based on machine capacity. • Worked in a cross functional team to collect and analyze machine capacity information.• Recorded machine breakdowns daily to identify the causes for machine downtime.• Communicated with engineers and machine operators to identify and solve process bottlenecks.