Lead R&D Engineer
Minneapolis, Minnesota, Us
Acted as chief engineer for startup projects. Roles included managing projects, interviewing customers, defining user needs, product requirements and specifications clinical hazards, regulatory requirements, human factors and usability, FMEA, UFMEA, verification, validation. Performed modeling, mechanical design, prototyping, and bench testing of devices; preclinical evaluation, statistical analyses, and clinical studies. Developed devices for radiofrequency catheter ablation and orthopedic surgery. Coauthored successful SBIR grant. Developed company quality (ISO 13485, CFR 820) and risk management systems (ISO 14971). Wrote quality manual and SOPs, such as design control, risk management, and supplier evaluation.