New Product IntroductionProcess DevelopmentLogistics and Strategy

Test systems and processes used to develop and manufacture medical device components. - Developed and established a validated state of the processes to successfully pass ISO 13485 audits.- Developed risk management and scheduling processes to maintain validation state resulting in standard work practices of validation procedures.- FDA Validation Audit – Validation of legacy processes and products resulting in 72 product family validations.- Coordinated and executed measurement system analyses (MSA) resulting in establishing data quality and reduced scrap rate in production departments.- Coordinated and executed Design of Experimentation (DoE) on plastic extrusion and injection molding processes resulting in process understanding and predictive models for future process behavior.- Leadership of validation projects that resulted in focused, positive team dynamics and addressed revalidation opportunities.- Coordinated and executed installation qualification (IQ) criteria that defined scope of validation projects.- Coordinated and executed the operational qualification (OQ) criteria that validated process operation parameters.- Coordinated and executed the performance qualification (PQ) criteria that established and verified the process behavior over an extended period of time.- Developed risk management to ISO 14971. Maintained process failure modes, effects, and analysis (PFMEA) resulting in ongoing risk management of processes.- Performed statistical analysis on engineering projects resulting in identification and prioritization of three new improvement projects.