-Responsible for managing JunoPacific Manufacturing Engineers, Engineering Technicians, and Process Engineers to best serve JunoPacific's production and NPI goals

-Responsible for the development and launch of a new sterilization management program at JunoPacific. Successfully qualified the sterilization management process, and passed a high profile OEM audit of the program.-Responsible for a site consolidation of JunoPacific's Redwood City facility into its Soquel site within a tight timeline, including equipment transfers, personnel transfers, mold transfers, qualifications, etc. Managed key customer supply chain risk, and made difficult priority decisions to best serve the business.-Managed the production transfer of a new start-up OEM cleanroom assembly product at JunoPacific, including manufacturing process development and training, equipment procurement, and qualification.-Managed a robust annual sterilization requalification project for a key OEM including quarterly bioburden monitoring, historical assessments, and a 5 cycle requalification activity (fractional cycle, half cycle, full cycle B/F, 2x Residuals)

-Validated FDA compliant assemblies involving parts, fixtures, equipment, and processes by writing and executing Installation, Operational, and Performance/Process Validations.-Wrote an extensive Master Validation Plan and Master Validation Report for a multi-component assembly which included all molding, testing, fixturing, and equipment requirements (including validation, calibration, and Preventative Maintenance)-Created manufacturing processes and operator instructions for both new and existing product lines-Responsible for reviewing and controlling BOM and part revision updates using a Document Change Order process-Defined processes and wrote the governing procedures for a sterilization management program-Used Minitab and statistical analysis to generate sampling plans and provide critical justifications-Participated heavily in Root Cause Analysis and CAPA completion-Performed risk analysis and generated FMEA reports-Handled complaints by communicating directly with customers in an organized and effective manner, from containment through corrective action phases-Experience leading projects and communicating timelines and status with key customers-Worked closely with various internal departments, and led cross-functional teams to complete validations and projects-Experience participating in Kaizen events, and driving improvement through the use of Lean Manufacturing tools-Organized with experience prioritizing and tracking a multitude of tasks