Experience

OXOS Medical

• United States
• Medical Device
• 1 - 100 Employee

• Director, Operations

  • Sep 2021 - Present

• Director, Program Management

  • Mar 2020 - Aug 2021



NFANT Labs

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director, Operations

  • Jan 2015 - Mar 2020

  DIRECTOR, OPERATIONS (January 2018 - March 2020) Digital Health company of FDA Class II IoT neonatal medical devices and feeding products • Oversaw operations, including Production, QA/RA, Purchasing & Receiving, Warehousing • Executed Oracle NetSuite ERP System Accounting, Transactions, Reports, Supply Chain Management, Tax Filings • Budgeted & evaluated demand planning for short-term and long-term growth needs • Oversaw external FDA audits OPERATIONS MANAGER (January 2015 - December 2017) • Built Google, Inc - Google Apps integrated Quality Management System (gDrive, gDocs, gSheets, gSites) compliant to 21 CFR 820 (US), ISO13485 (International), and 45 CFR 160 (HIPAA) standards • Managed new Product Development, including Project Management, Sourcing, Specifications, CAD/drawings, Injection Molds, Tooling, Bill of Materials, Labeling, Packaging, Validation of Software/Equipment, Design Controls, Regulatory Compliance • Directed all employee & contract training to GMP, HIPAA & HITECH standards • Oversaw internal & vendor audits Show less



Global Center for Medical Innovation (GCMI)

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Biomedical Engineer

  • Oct 2013 - Dec 2014

  Medical Device R&D: • Prepared 510K & regulatory documentation for FDA Class II medical devices • Skilled in IoT electromechanical devices, silicone and plastic injection molded components • Developed Prototype & Production Tooling Medical Device R&D: • Prepared 510K & regulatory documentation for FDA Class II medical devices • Skilled in IoT electromechanical devices, silicone and plastic injection molded components • Developed Prototype & Production Tooling