As a Senior R&D Engineer, I spearheaded innovation in new medical instruments, contributing significantly to the expansion of the company's product pipeline. I managed the early-stage product development cycle for various concepts. This led to cross-functional collaboration with marketing and leadership where we managed VOC cadaver labs to collect feedback and R&D cadaver labs to evaluate product performance and usability. I developed characterization tests to optimize the various instruments performance and durability with prototypes to quickly iterate on new concepts. Additionally, I improved existing on-market instruments performance and usability, while implementing new manufacturing processes that reduced kit COGS.

As an R&D Engineer, I played a role in the development of various medical device instruments, from prototyping to product launch. I led Voice of the Customer (VOC) sessions with physicians and key leadership, ensuring the design met clinical functionality and provided an excellent user experience. My responsibilities included designing products for manufacturability and validating both the manufacturing processes and the complete instrument set to ensure successful launch.

As an R&D Engineer, I successfully transitioned early-stage prototypes into production-ready products by implementing design for manufacturing techniques like over molding and laser welding. The improved DFMA led to a 20% reduction in manufacturing costs and increased throughput in production. I developed and implemented specifications, including Lot History, MWIs, Control Plans, Manufacture Drawings, and DV&V Testing, for five different biomedical companies. Additionally, I collaborated with clients to create and maintain Design History Files (DHFs), including DMRs/MDF, DIDO matrices, Risk Analysis, DV&V Testing, Regulatory, and Product Specifications.I worked with small startups and key physicians to develop medical instrument concepts and early-stage devices for clinical use and animal studies.

-Designed, prototyped, and manufactured custom medical housing units for initial run and marketing.-Participated in regulatory activities for testing and validation on medical products.-Established manufacturing procedures for product specifications.

-Reviewed projects and production costs for manufacturing architectural components.-Reviewed and corrected CAD drawings for manufacturability.-Manufactured components to prints using a variety of machines.

-Designed and manufactured custom soft jaws, stops, and fixtures for products to produce reliable components.-Hand worked components to achieve tactile feel along with QC inspection for critical features and dimensions.