Jon Huber Email & Phone Number

Knoxville, Tn, Us

Directed daily operations and project management efforts, resulting in two FDA 510(k) clearances for 3D-printed surgical instruments and implants designed for craniomaxillofacial procedures, as well as the development of a complementary web-based surgeon visualization portal. Facilitated strategic partnerships, culminating in the acquisition of the company by a leading orthopedic medical device provider. Managed a multidisciplinary team of 25 in the U.S. and coordinated with 80 personnel across four international companies. Oversaw recruitment, staffing, and resource allocation to meet project milestones, adhering to FDA 21 CFR Part 820, ISO 13485, ISO 14791, and IEC 60601-1 standards. Administered project tracking and Agile workflows using Jira and Roadmunk, and developed automated reporting systems. Directed testing schedules, including biocompatibility, bioburden, chemical characterization, and sterilization in accordance with ISO standards. Conducted structural analyses for FDA submissions and implemented AI-based solutions to streamline regulatory documentation and submission processes.

Knoxville, Tn, Us

Lead the development and transfer of innovative technologies, including advanced 3D wireless positioning systems, health monitoring devices, diagnostic algorithms, and environmental impact reduction initiatives. Defined strategic roadmaps for research and development, overseeing the design and transfer of high-precision RF-based positioning systems. Led the creation of diagnostic devices and learning algorithms aimed at enhancing health monitoring capabilities. Directed environmental sustainability projects to minimize ecological footprints. Managed a cross-disciplinary team of electrical, mechanical, and firmware engineers to develop feasibility prototypes and transition concepts into production. Secured eight patents across diverse fields, encompassing wearable device interfaces, detection algorithms, fluid dynamics, and smart devices.

Led the development of vCAD, a cloud-based SaaS platform that automates the conversion and distribution of 3D models for enhanced accessibility across mobile, web, and VR platforms with real-time data integration. Managed a multidisciplinary team of 3D artists and full-stack developers to design and implement vCAD, supporting diverse software such as Revit, SolidWorks, Rhino, Maya, Blender, and 3DS Max. Spearheaded development for Android, iOS, and web platforms using WebGL, AWS, and JSON, with optional VR modes built in Unity3D. Innovated navigation and UX features to improve visualization and reduce VR motion sickness (vestibular mismatch). Integrated real-time metadata from a cloud SQL database to support personalized user experiences, including preferences, model sharing, and in-space annotations.

Maryville, Tn, Us

Directed mechanical and electrical engineering efforts for a Proton Therapy System achieving two FDA 510(k) clearances. The system delivers proton particles at two-thirds the speed of light with submillimeter accuracy to target tumors. Managed the project from concept through FDA submission, including the design and construction of a 6,000 sq. ft. facility, leveraging AutoCAD for building design and SolidWorks for device design. Oversaw installation of extensive infrastructure, including 2 miles of water cooling lines and 25 miles of power and sensor cables. Developed design specifications, drawing standards, change control processes, and DFMEA, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14791, and IEC 60601-1. Trained staff in Six Sigma methodologies and automated data processing using Excel VBA, Python, and MATLAB. Built and maintained a cross-disciplinary team, establishing key vendor relationships. Awarded 9 patents across areas such as patient tracking, rotational accuracy, human interface optimization, and image processing.

Maryville, Tn, Us

Maryville, Tn, Us

Knoxville, Tn, Us

Taught and mentored engineering students, emphasizing practical, hands-on learning and real-world problem-solving. Delivered instruction in foundational courses such as Statics, Dynamics, Computer Drafting (Mechanical Desktop), and MATLAB programming. Developed and coordinated lectures, team-based projects, and lab experiments to enhance student engagement and understanding. Mentored senior design projects, providing guidance on project planning, design, and execution.

Ithaca, New York, Us

Led the development and optimization of the NanoTek LF, a cutting-edge microfluidic chemistry system for radiopharmaceutical drug development and clinical dose production, with a focus on synthetic organic synthesis and biomarker pharmaceuticals. Designed microfluidic components using SolidWorks, employing CNC machining and silicone casting for fabrication. Implemented Six Sigma methodologies and Design of Experiments to integrate hardware, software, and process controls, ensuring system capability. Developed Excel VBA tools for real-time data visualization and analysis, enhancing on-site support. Achieved a significant breakthrough in synthetic organic synthesis for biomarker production and collaborated with researchers to expand the system's applications.

Morgantown, Pennsylvania, Us

Led the development of advanced airbag inflator technology, focusing on high-performance, cost-effective designs optimized for large-scale production. Designed components and assemblies in SolidWorks, utilizing FEA simulations to enhance performance and manufacturability across various production methods, including stamping, machining, forging, casting, and injection molding. Specialized in high-pressure applications (20,000+ psi) and ultra-high-tensile materials (120,000+ psi), employing diverse welding techniques such as MIG, TIG, friction, resistance, and laser welding. Applied Six Sigma Black Belt methodologies to conduct Design of Experiments, testing, and DFMEA to ensure safety and reliability. Utilized SQL and Excel VBA scripts for data analysis, monitoring production variability, and improving processes.

Doctor Of Philosophy (Phd), Biomedical/Medical Engineering

M.S., Engineering Science

B.S., Biomedical Engineering