New Product Development (Intern)
• Company manufactures medical equipment such as Blood Collecting Tubes, Insulin Syringes, Insulin Pen Needles, etc.• Work in Research and Development, specifically in new product development.• CAD designing and drafting completed before sending designs to Quality Assurance department.• Documentation of revisions, protocols, and reports for the product are part of responsibilities.• Verification & Validation reports generated for all equipment.• Maintain Design History File for all revisions.• Implement control plans and workflows for all revisions and reports, following ISO 13485 standard.• Completed a 510K project, including a comparison study, precision study, IFU, etc., showcasing expertise in regulatory affairs and product development within the medical device industry.