Skills:
Product Development: Cross-Functional Team Leadership, Medical Device Innovation & Design, Verification and Validation Testing, SolidWorks, Lean Manufacturing, Frugal Engineering, RF Welding, Disposables, Fabrication, Ultrasonic Welding, Catheter Manufacturing, Gamma Irradiation, Steam and Ethylene-Oxide Sterilization, Mass Flow Leak Testing, Technical Writing for Grants and Journal Publications, Microsoft Office, Minitab, Design of Experiments, Statistics, Human Factors Engineering, User-Centered Design, Finite Element Analysis, SPC. Quality System and Regulatory: 21 CFR Part 820, ISO 13485/9001, CAPA, Risk Assessment, Complaint Resolution, Route to Market Strategy, Clinical Study Design, Audit Experience (DHF, Design Controls, QMS), Investigational Device Exemptions, New Drug Approvals, 510(k) submissions. Business: Intellectual Property, Reimbursement, Market Entry & Commercialization strategy, Stakeholder Management, Project Management, Market/Landscape Analysis