Provide engineering support services, as required, in support of the continued commercialization of the Venclose RF Ablation System during integration into the Becton Dickenson Peripheral Intervention QMS.

Support development and implementation of design and manufacturing process changes for the Venclose RF Ablation System through development and release of documents in the Venclose Quality System. Lead/monitor implementation of changes at contract manufacturers. Review and approve resulting CM document changes.

Provide input to and active support of on-going contract manufacturing operations for new medical devices.

Member of production risk management remediation team developing process risk analysis documents (pFMEA) for both implant and instrument products.

Member of a Quality System remediation team - used gap analysis to determine compliance requirements for Acclarent's Quality System and J&J Quality Standards related to Change Controls and Material Controls, Worked with J&J corporate auditor to achieve closure of issues.Developed SOP and Work Instructions providing Material Controls for the storage and handling of field inventory held by off-site sales personnel.

Provided technical support during transfer of medical RF Generator manufacturing and test processes to off-shore contract manufacturer (Ireland).Provided engineering support to multiple catheter manufacturing lines during re-organization and transfer of manufacturing to off-shore CMO. Investigate and resolve material/component quality issues.Ensured continued operation of two prototype balloon coating production lines during ramp-up to full production. Developed laser based measurement system to enable accurate measurement of balloon diameter to ensure dosage consistency. Established and validated pouch fill process parameters for hermetically sealed pouch to minimize seal failures during transportation.

Support development of the Stryker Neurovascular QMS through development of SOP and work instructions for Calibration, Supplier Controls, Incoming Quality Assurance and Material Specifications/Inspection Procedures. Support supplier development through selection, onboarding, maintenance and audit. Oversee the smooth integration of the Incoming Quality Assurance laboratory and processes from Boston Scientific to Stryker Neurovascular to ensure equipment and processes meet SNV quality requirements.

Worked to develop strong collaborative relationships with service and component suppliers to ensure the continuous supply of compliant materials to manufacturing from both on-shore and off-shore sources.Supported day to day operations through support of incoming inspection activities and development of part specific inspection procedures, work instructions for First Article Inspection and Supplier Process Change Control, Improved overall level of incoming quality in areas of responsibility through supplier support/development, development of component specific Quality Plans for complex outsourced catheter assemblies, qualification of new molds and validation of supplier processes. Worked closely with internal and external cross-functional teams to qualify new laser welding and sub-assembly suppliers.

Review material specifications and develop specification changes to improve technical communication and ensure the continued supply of materials and components that meet design and quality requirements..

Development and validation of new manufacturing processes for implantable infusion pump.Team Leader:Validation and support of manufacturing and test system software.Development, validation and support of catheter and ancillary product manufaturign and test methods.Development, validaton and support of chemical cleaning processes.

Work closely with suppliers to establish partnering relationships, develop qualified supplier manufacturing processes and the delivery of compliant materials, on time, during commercial scale-up for new drug product.

Led pre-launch validation of automated assembly control systems and post-launch OEE improvement projects.

Technical oversight and support of Incoming Quality Assurance.

Retrospective and prospective validation of test methods, manufacturing processes for lung ventilators. Development and transfer to production of manufacturing processes for new products.

Development, validation and transfer to production of manufacturing processes for Falcon catheter. Manufacturing team leader during design verification testing and process validation.

Team member in the development and transfer to production of the 2470-III wire bonder. Developed hardware packaging for after-market ECU for 2470-II wire bonder. Developed and implemented new product configuration for 2470-II and 2470-III.