SymPhysis Medical are Making Every Day Count for cancer patients undergoing palliative care. Our emergent technology, releaze, is designed to reduce hospitalization and increase patient independence for patients experiencing fluid build-up as a result of cancer.

Program Manager on assignment in Costa Rica responsible for managing intercompany operations transfers.

Project Manager on New Product Introduction

Project Manager for product Transfer.Responsible for project schedule, resource planning, budgeting OP-Ex and Cap-ex budgets and project T&C’s.Manage project risk activity and drive mitigation activity.Manage project scope.Complete periodic project status updates and reviews.Manage site wide project stakeholder communications.

Responsible for Computerized Systems Validation across multiple new lines.Complete Validation Strategy.Process & Product Validation on 2 new Products.Test Method Validations.

Responsible for project schedule, resource planning, budgeting OP-Ex and Cap-ex budgets and project T&C’s.Manage project risk activity and drive mitigation activity.Manage project scope.Complete periodic project status updates and reviews.Manage site wide project stakeholder communications.Manage projects with Op-Ex budgets >1.2M Cap-Ex 5M for 1 year to 5 year duration.Project Manager on successful US product Transfer to the Galway site from US site to be sole manufacture of a DES Stent product.Operations Project Manager on multiple NPI PDP’s PI Balloon Catheter device. PI DES Self Expanding Stent IC Cutting Balloon Device. Project Lead on Op’ s PM system project. To implement a standard and central Ops Project Office for the Operations.

Manufacturing Engineering Project lead on automated line installs, involving machine set-up optimization and CSV execution.Executed multiple cathether Process Validation on automated lines for NPI and additional product capacity. Project (SDC) team lead on introducing new product to Galway.Project lead on multiple projects to implement Lean and Six Sigma problem solving methodolies to drive process improvements, increase productivity and decrease cycle time, determine root causes of manufacturing issues and implement effective corrective/preventative actions. Work with different functions, value streams and sites on resolving issues.Implemented IPM Test Cell. Worked with multiple vendors on IPM equipment, from purchasing to machine maintenance and technical training.Involved in CSV and Process Validation activities from Protocol creation through execution. IQ, OQ PV, FMEA,PSV, ATMV and VTMV creation through execution. Current BSCI PV SME team member.Supported the day-to day manufacturing process by addressing equipment performance issues. Set-up training systems for knowledge transfer and technical references on these issues

Provided process/quality support to manufacturing to ensure delivery of the highest quality product.First point of engineering contact for manufacturing issues. Sole engineering coverage at weekends.Responsible for process parameter control, targeting performance, excursion prevention and layer/product capacity, statistical process control, yield improvement, data analysis and problem solving. .Designed and implemented Engineering Projects in the areas of cost reduction, process improvement and tool availability improvement. Supervised and supported process validation activities for new product implementation.