Process Validation and Project Management of Programs to expand and ensure manufacturing capacity.

Validation SME managing validation projects and leading teams for remdiating Production and Process controls. Performing gap analysis and conducting IQ, OQ, PQ and Test Method Validations.

Project management leading design updates and process remediation. Validation SME performing TMVs and remediation of processes for electro-mechanical blood pumps.

Managed plant activities for process development, validation and assembly of various Medical Devices for contract services. Developed company validation testing strategies for IQ,OQ and PQs, packaging and sterilization of Medical devices per PDP plans. Company is certified ISTA packaging test lab and contract sterilizer.Achieved 42% labor efficiency gain on major assembly line. Oversaw 15 development programs/ customers simultaneously. Established metrics and reporting system for project… Show more Managed plant activities for process development, validation and assembly of various Medical Devices for contract services. Developed company validation testing strategies for IQ,OQ and PQs, packaging and sterilization of Medical devices per PDP plans. Company is certified ISTA packaging test lab and contract sterilizer.Achieved 42% labor efficiency gain on major assembly line. Oversaw 15 development programs/ customers simultaneously. Established metrics and reporting system for project status updates to customer and staff. Upgraded the Quality and Engineering departments with personnel and procedures to expand services in the areas of FAI, process development and Quality related services. Instituted statistical process control. metrics and Validation methodologies for improved quality and reporting capabilities. Implemented Lean / Six Sigma program for manufacturing cost improvements. Show less

Design, Development and Manufacture of Orthopaedic surgery devices.

Plant Operations leader for the contract development and manufacture of an array of sterile, single use Medical devices supporting 35 major customers producing over 250 diverse SKUs. Oversee Production, Sustaining Engineering, Facilities, Maintenance and Safety. Plant produces $120 MM in outsourced product income translating to over $600 MM in product value at the end user. Identified and spearheaded multiple programs leveraging lean manufacturing, scrap reduction, CIP and Six Sigma… Show more Plant Operations leader for the contract development and manufacture of an array of sterile, single use Medical devices supporting 35 major customers producing over 250 diverse SKUs. Oversee Production, Sustaining Engineering, Facilities, Maintenance and Safety. Plant produces $120 MM in outsourced product income translating to over $600 MM in product value at the end user. Identified and spearheaded multiple programs leveraging lean manufacturing, scrap reduction, CIP and Six Sigma methodologies for significant cost savings and cycle time reduction across multiple product lines. Achieved over $10MM in cost savings over last 4 years implementing CIP programs. Established performance metrics and report plant progress on a monthly basis to executive management. Show less

Managed Facility expansion including buildout for additional cleanroom. Re-organized and streamlined Warehouse and Production areas leading to successful ISO/FDA facility approval.Spearheaded program for company wide ERP (Expandable) software selection and successful implementation within 3 months. Implemented Kan ban (pull system) system in production and warehouse areas.Scaled up operations staff for production launch of product. Lead program to boost capacity from 1000 to… Show more Managed Facility expansion including buildout for additional cleanroom. Re-organized and streamlined Warehouse and Production areas leading to successful ISO/FDA facility approval.Spearheaded program for company wide ERP (Expandable) software selection and successful implementation within 3 months. Implemented Kan ban (pull system) system in production and warehouse areas.Scaled up operations staff for production launch of product. Lead program to boost capacity from 1000 to 3000 units per month involving over 120 SKUs. Enhanced product for improved performance and safety. Implemented programs to reduce product cost and streamline process. Saved over $440 K/yr in materials costs through vendor negotiation and blanket purchase agreements. Show less