3DISC Americas, Inc.
I led the hardware development in the R&D department from concept to fabrication of intraoral scanners, which produce a 3D model of a dental patient's mouth for various procedures. Collaborating with a small multidisciplinary group of engineers/scientists, we created a scanning technology that some of the largest dental technology manufacturers could not accomplish.
● Spearhead the design and development of Intraoral Dental Scanners from concept to production
● Successfully met quality system and regulatory requirements of US FDA, Health Canada, Brazil ANVISA , Korean FDA and various other regulatory bodies for usability/ergonomics, human factors, biocompatibility, product safety, product packaging and sterilization.
● Work product conformed to medical device design controls requirements of FDA 21CFR820 and ISO13485
● Develop a comprehensive understanding of project requirements, target audience, and business objectives by working with cross-functional teams, which included Electrical, System, Mechanical, and Optical engineers
● Create parts, assemblies, and drawings for various materials and manufacturing processes, including custom optical assemblies, PCB/FPC footprint and critical component placement, CNC metal, stamped metal, injection-molded plastic components, and OTS hardware
● Drive innovation within a compact, international, and diverse team of engineers and scientists, leading to the development of a scanning technology that outperformed the capabilities of major competitors
● Generated detailed sketches, 3D models, prototypes, and mock-ups to communicate design concepts to stakeholders effectively
● Partnered with on-site manufacturing teams to develop, and refine production by creating assembly documents, troubleshooting fabrication issues, designing a fabricating fixtures, evaluating returned products, and optimizing workflow
● Cultivated strong relationships with 10+ domestic and international suppliers including travel to China, guaranteeing quality and timeliness of prototypes, tooling, jigs, and final parts for approval
● Managed international labeling, conducted external testing, and met all regulatory requirements for medical device; passed all regulatory audits with 0 findings on work product
● Generated and refined design concepts based on user feedback, technical feasibility, and market trends, resulting in a product optimized for manufacturability, reliability, and quality standards
● Coordinated simultaneous projects, including packaging development and testing, re-branding for OEM customers, cross-departmental consultations, and concept/feasibility exploration