Kii Fixation and Balloon Trocars - Oct 2017 - May 2018Gel Access Systems- May 2018 - November 2021

Group Process Development: Kii Advanced Fixation and Balloon Trocar • Qualifying cost-reduction and product quality process improvements into Production (IQ/OQ/PQ/PPQ).• Working with Clinical Development, R&D, Quality, Regulatory Affairs, Calibration, Purchasing, Planning, and Production departments to meet project goals.• Designing, testing, and qualifying fixtures/equipment to improve standardized functional testing and manufacturing methods.• Performing Test Method… Show more Group Process Development: Kii Advanced Fixation and Balloon Trocar • Qualifying cost-reduction and product quality process improvements into Production (IQ/OQ/PQ/PPQ).• Working with Clinical Development, R&D, Quality, Regulatory Affairs, Calibration, Purchasing, Planning, and Production departments to meet project goals.• Designing, testing, and qualifying fixtures/equipment to improve standardized functional testing and manufacturing methods.• Performing Test Method Validation on Engineering and Production test methods using statistical techniques.• Performing Software Validation on Manufacturing/Quality Equipment.• Dispositioning non-conforming product, performing root cause analysis, and implementing corrective actions.• Providing engineering support to diagnose, troubleshoot, and resolve production issues.• Overseeing management on all projects allocated to a sub team of Process Engineers, Associate Engineers, and Engineering Technicians. Show less

Group Process Development: Kii Advanced Fixation and Balloon Trocar • Qualifying process improvements and new equipment into Production (IQ/OQ/PQ).•Working with Clinical Development, R&D, Quality, Regulatory Affairs, and Production departments to meet project goals.• Designing, testing, and qualifying fixtures to improve standardized functional testing and manufacturing methods.•Perform Test Method Validation on Engineering and Production test methods using statistical… Show more Group Process Development: Kii Advanced Fixation and Balloon Trocar • Qualifying process improvements and new equipment into Production (IQ/OQ/PQ).•Working with Clinical Development, R&D, Quality, Regulatory Affairs, and Production departments to meet project goals.• Designing, testing, and qualifying fixtures to improve standardized functional testing and manufacturing methods.•Perform Test Method Validation on Engineering and Production test methods using statistical techniques.• Dispositioning non-conforming product, performing root cause analysis, and implementing corrective actions.• Providing engineering support to diagnose, troubleshoot, and resolve production issues.• Supervise and assist in development of Process Engineers, Associate Engineers and Engineering Technicians. Show less

Continuation of internship from 2013.• Designed support structures & heat sink assemblies for different power supplytesting equipment applications.• Minimized cost & ensured ease of manufacturability for each project.• Provided manufacturing drawings and assembly assistance.• Designed chassis to mount in nose cone for wind-tunnel project with Raytheon.

• Designed service/retail case for company’s YAG/SLT laser systems.• Provided viability assessment of a forthcoming biochip technology.• Worked with R&D manager to implement HUD technology intoYAG/SLT optical layout.

• Designed support structures & heat sink assemblies for different power supplytesting equipment applications.• Minimized cost & ensured ease of manufacturability for each project.• Provided manufacturing drawings and assembly assistance.

• Learned various marketing tactics to pursue higher sales of concessions.• Assisted customers with financial transactions & maintained theater cleanliness/appearance.

• Learned various marketing tactics to pursue higher sales of concessions.• Assisted customers with financial transactions & maintained theater cleanliness/appearance.