Principal Mechanical Engineer
CurrentTechnical lead for a multi-site cross functional team of Quality, Regulatory, Manufacturing, and R&D developing new Class III catheters, introducers, and dilators for the treatment of atrial fibrillation via cardiac RF ablation technology through minimally invasive techniques. • Conducts research leveraging bench, porcine, and cadaver models for feasibility evaluation, specification development, and design validation. • Creates product development documentation under FDA and EU MDR design controls (CFR 820, ISO 13485) to support the submission of 510(k) and PMA certifications. Collaborates on defining product requirements, aFMEAs & dFMEAs, usability, models, and drawings. • Designs test methods and fixtures based on clinically relevant data to evaluate device performance in parallel with requirement creation. E.g. System performance, mechanical loading and durability, anatomical pathways definitions, system performance. • Leads design verification and validation activities. Writes and executes test protocols and reports documenting test procedure and equipment. Directs engineers, co-ops, and interns in the execution of design activities and test protocols. • Lead a product enhancement and cost reduction project for a cardiac cryo-ablation probe. Successfully launched 510(k) approved product realizing an annual savings of $300k. • Led research of new technologies for surgical procedures. Sourced a vendor as a development partner and defined the feature set. Created prototypes, led feasibility testing, and evaluated at pre-clinical labs. Presented finalized design plan to executive leadership that enabled business strategy planning. • Extensive use of 3D Printer capabilities. Curates printer facilities and trains colleagues enabling the creation of prototypes, test equipment, and fixtures for feasibility, development, and laboratory purposes.
