AMBERLY SHISLER

• Conduct thorough testing with Senior Packaging Engineers on 11 legacy packaging systems to verify conformance to ISO 11607-1 and implement new packaging system changes in production.
• Provide subject matter expertise in cleaning and sterilization of surgical instruments in accordance with AAMI and ISO standards for all NPD projects.
• Developed and executed a project for design and development of sterilization containers which reduced project lead time from more than 2 years to 1 year and reduced documentation from 2 DHFs to 1.
• Conduct technical investigations to close CAPAs, NCs, and complaints, determine root cause of quality issues, and implement corrective and preventative actions.
• Perform validations on packaging equipment by drafting and executing IQ/OQ/PQ documentation in accordance with ISO 11607-2.
• Collaborate in investigation and repairs of machine issues with maintenance and packaging technicians as well as evaluate and implement requested improvements in clean room environment.
• Draft and execute testing protocols and reports for packaging in accordance with ASTM standards and company procedures to support NPD and vendor requested changes to packaging to verify compliance to design inputs.
• Manage multiple NPD and sustaining projects, collaborate with various E&D and manufacturing groups to complete all project deliverables on time.
• Evaluate new cleaning, sterilization, and packaging standards and perform gap assessments to find and propose project plans and testing to maintain compliance to all applicable standards.
• Provided technical support to manufacturing teams during package assembly process, troubleshooting issues as they arose.
• Conducted evaluations of equipment and machinery to verify optimal performance and efficiency.
• Developed and implemented a tooling change that reduced machine down time by 20%.
• Monitored and optimized production processes to increase throughput and improve quality.
• Ensured compliance with industry regulations, maintaining up-to-date knowledge on packaging standards and guidelines.
• Served as subject matter expert for packaging-related inquiries from other departments, providing guidance and support as needed.
• Streamlined production processes by implementing new packaging equipment and tooling, increasing overall productivity.

• Led the planning, development, implementation, and maintenance of electronic DHR packets and SAP-MES system in the Gainesville location on 22 product lines and trained Production technicians, Manufacturing Engineers, and Quality Engineers on the use of SAP-MES
• Created and maintained work instructions, procedures, and forms utilized across production that met and complied with established Quality and Regulatory Standards
• Collaborated with Production, Quality, and Regulatory personnel in the implementation of SAP-MES to verify it is functional for the manufacturing environment
• Utilized SAP-MES to analyze and identify process improvements to reduce production time for MR Coil manufacturing and streamline processes between different product lines
• Assisted in the development of IQ/OQ/PQ documentation and execution on MR Coil manufacturing as well as assisting with software validation
• Collaborated with Software Engineers in the integration of ATEs with SAP-MES electronic record systems
• Provided engineering guidance and support for all Kaizen and Lean Six Sigma events.
• Developed technical documentation, including standard operating procedures, work instructions, and engineering drawings to support manufacturing operations.
• Improved manufacturing efficiency by streamlining production processes and implementing lean methodologies.
• Identified problems and specific resolutions to fix defective, damaged, or malfunctioning parts, assemblies, equipment and systems.
• Researched and tested design feasibility and operation of equipment, components and systems.

• Supported Manufacturing Engineers with the maintenance of the Label Printing System and verified labels met quality standards
• Processed Non-Conforming Material Reports, verified the material had been inspected by the Manufacturing Engineers, and all documentation was completed properly to process the material in SAP-ERP.

• Processed engineering changes to engineering drawings and documentation in Agile Product Lifecycle Management, SAP, and SolidWorks Enterprise Document Management System (EDMS)
• Coordinated engineering changes from submission through to implementation on manufacturing floor
• Supported Product Development Engineering in the creation of specification documentation including CAD drawings, test, and tune procedures
• Assisted senior management with project changes to EDMS
• Provided guidance to other employees on completion of changes to documents and drawings.