Vascular Sustaining R&D

• Performed statistical analysis and validation measures on batch record data to assess deviations and variances in critical process parameters to maintain critical quality attribute specifications. • Investigated data trends to maintain and improve process yields and accountabilities as well as reduce post manufacturing material waste. • Reviewed Executed Manufacturing Batch Records to ensure procedures and data were compliant with FDA standard Good Manufacturing and Documentation Practices (GMP & GDP). • Structured specific commercial manufacturing guidelines for an official internship program in order to streamline the learning process of industry knowledge and competencies.

• Narrowed prototype concept design focus through statistical analysis of human factors testing and research.• Performed extensive design verification testing and applied physiological environment factors research to validate product performance standards.• Effectively communicated between executives and team members by presenting progress at meetings.• Worked with process development teams to assess key product functionality features.• Author of technical documents such as test protocols, implementation history documents, anddesign verification reports which all contributed to the project knowledge base.

• Increased manufacturing volume by operating injection molding machines and extrusion lines for medical devices including catheters, needles, and surgical equipment.• Utilized engineering drawings, electron microscopy, and laser imaging inspection to improve process efficiency.• Maintained company standards through attention to detail in work, quick adaptation to environment, and dedicated production ethic.