Leadership and Oversight:- Led a team of engineers as Technical Project Lead and SME, guiding design decisions and creating roadmaps to meet project milestones.Project Planning and Management:- Developed and managed R&D project plans, presenting timelines and milestones in monthly management meetings to ensure alignment with expectations.Design and Prototype Development:- Directed the design, improvement, and optimization of a surgical implant and its delivery system from concept to 3D-printed and machined prototypes.R&D Support and Training:- Managed R&D tasks, instructing and training technicians and engineers.Collaborative Planning:- Partnered with the Project Manager to define project requirements, milestones, and budget needs, and prepared documentation for PMA submissions.Supplier and Manufacturer Evaluation:- Identified and assessed potential manufacturers and suppliers; conducted tolerance stack-up analyses to ensure manufacturability.Process Improvement:- Created process flow charts and designed assembly and inspection fixtures to enhance production and assembly efficiency.Product Design and Testing:- Evaluated designs for critical features, utilized 3D printing and fabrication for testing and demonstrations with Key Opinion Leaders (KOLs).Quality Management System (QMS) Enhancements:- Conducted gap assessments of QMS standards, developed protocols and test methods for seal strength inspection.Testing and Analysis:- Facilitated Gauge R&R sessions with technicians, interpreting results with Minitab.Supplier Qualification and Audits:- Qualified suppliers through PPAP, conducted QMS audits, and discussed design and manufacturing processes.Manufacturing Process Integration:- Collaborated with sustaining engineers to integrate new manufacturing processes into existing product flows.

• Reverse engineer OEM parts by utilizing measuring tools such as calipers/micrometers, drop gages, RAM optical, tool scopes, Oasis Vision system, and optical comparators.• Develop inspection methods, milling fixtures, inserts, and tools for manufacturing.• Collaborate with manufacturing team to create milling strategies using MasterCAM X9 for Haas OM-2a.• Identified and implemented new solutions for manufacturing processes.• Provided official training in general GD&T and manufacturing inspection to floor inspectors.• Lead a team of engineers in projects involving new product lines and extensions.• Initiate correspondence with the Federal Drug Administration in regards to 510(k) responses.• Facilitate and coordinate design meetings with cross functional teams (Purchasing, Sales, Marketing, Manufacturing, Regulatory Affairs, and Quality Control) to develop new product lines, as well as review any new engineering change orders and its effect on risk.• Produce design history files by performing design input, output, verification, validation, and transfer activities through written protocols, reports, risk assessments (FMEA), and statistical analysis.• Manage multiple projects using Microsoft Project as an organization and documentation tool.• Design CAD models and drawings of medical class I and class II dental products utilizing SolidWorks.• Practice GD&T (ASME Y14.5) and DFM/DFA in drawings.• Utilize finite element analysis features in SolidWorks/Fusion 360 to perform stress analyses, thermal, and flow simulations; render tools for marketing teams; motion study.• Design packaging for new and existing products.• Prototype parts for R&D/Manufacturing/Packaging using conventional lathes/mills and 3D printers.• Communicate with vendors/suppliers aimed at testing for R&D projects, tooling for manufacturing, and general machining for packaging/processing.