Hardware, Software, and Assay SYSTEM Integration for ImmunoAssay/Clin Chem Diagnostics

New Product Development

• System Integration with Assay Applications/Design Control Reagent Cross-Contamination (Carryover) protocol execution and summaries (OEM, TDM, DOA) Aeroset System Software V&V for version 1.03  System level Regression Testing Plans and Protocols for c8000 Wave 1 Assay Performance regarding changes to HW/SW/FW 2002-2003 launch. Protocol Preparation/Execution– c8000 ICT Assay Design Verification Protocol Status updates/Summaries/ Data Presentation Data Collection, Summary and Data Package Compliance to OPs Assay Disk FD/CD Verification and Validations First Lot to Stock Kit/product/labeling/installation verification Document Control for Record Retention Administrative coordination of Kronos time clock, Non-Inv Purchase requisitions

• System V&V / Design Control Consistent collaboration with Software Engineering on all pertinent activities, including: test function and math models. Communication and Actions between System Integration and external Software Consultants SWRS (Software Requirement Specifications) revision process with SI management Generate/edit numerous documents to meet new design control process requirements Document Alcyon Analyzer System Risk Analysis for compliance Create/Modify Protocols for SW Features Verification  Generate and submit system V&V summaries for SW revisions.

System Integration with CLIN CHEM Analyzer Assay Applications/Design Control, 2005-2010Reagent Cross-Contamination (Carryover) protocol execution and summaries (OEM, TDM, DOA)Technical Analysis: Conducted experiments according to plan. Interpreted experimental results to draw conclusions and recommend options for next steps. Recognized and assisted with the resolution of technical problems. Utilized technical literature to expand technical and theoretical understanding. CLIN CHEM Analyzer, Aeroset System final Software v1.03 improvements for Verification &Validation, 2004 System level Regression Testing Plans and Protocols for CLIN CHEM ANALYZER c8000 Wave 1 Assay Performance regarding changes to HW/SW/FW 2002-2003 launch.Protocol Preparation/Execution- c8000 ICT Assay Design VerificationProtocol Status updates/Summaries/ Data PresentationData Collection, Summary and Data Package Compliance to OpsAssay Disk FD/CD Verification and ValidationsFirst Lot to Stock Kit/product/labeling/installation verificationDocument Control for Record RetentionAdministrative coordination of Kronos time clock, Non-Inv Purchase requisitions

Generate Protocols and Test execution for SW Features Verification; Generate and submit system V&V summaries for SW revisions.Consistent collaboration with Software Engineering on all pertinent activities, including: test function and math models.Communication and Actions between System Integration and external Software ConsultantsGenerated design control documentation to meet process requirements and SWRS (Software Requirement Specifications)Document CLIN CHEM bench-top Analyzer System Risk Analysis for compliance

• Manage the complaint handling procedures to document product complaint investigation for both reagent and software inquiries.• Coordinate all information relative to complaint investigations between departments, including Regulatory, Evaluation & Applications, Marketing, Technical and Engineering Support.• Ensure the complaint investigation files contain completed documentation with conclusions to satisfy the original customer complainant and fulfill internal regulatory expectations for GMP.• Continue to support instrument/reagent customers as well as Olympus field and account representatives on the five Olympus systems.• Analyze and offer solutions to customer concerns regarding instrument and reagent problems on any of five different Clinical Chemistry systems for Olympus.• Coordinate with engineering support and field service staff to resolve problems with instrumentation. • Coordinate with the Evaluation and Applications department to resolve specific chemistry concerns and to document product lot inquiries.