Technical lead with over 16 years of experience in biotechnology and the medical device industry, along with 13 years of supervision and management experience, seeks to expand responsibility and provide influence over future class of engineering professionals.Strong knowledge of the entire design and development process of medical devices, from concept generation through design verification, process development and into full scale manufacturing. Experienced in clean room manufacturing and laboratory settings with the following: catheters and delivery systems, delivery system accessories (introducers, sheaths, loaders), plastics/extrusions, balloon molding, self-expanding and balloon-expanding stents, guidewires, embolic protection, ECG, EEG, microfabrication/BioMEMS, embolism coils, drug delivery, and drug eluting stents. Academic background includes biomedical engineering, materials science, systems engineering, and management. Industry background includes project management, cost avoidance and cost improvement, defect reduction, corrective/preventive actions (CAPA), lean, product development, root cause analysis, six sigma, proof of concept, statistical analysis, equipment/process validation, packaging, sterilization, and automation.
Listed skills include Medical Devices, Fda, Capa, Validation, and 30 others.