Dave Toth Email and Phone Number

-Leader of Illumina's multi-year, global initiative to evolve its Quality Management System to emphasize value for customers and the business beyond compliance.-Quality Investigation Program Manager for Illumina's Product Field Action process.-Continued leadership of Illumina's Global Product Risk Management Process (ISO 14971).-Continued leadership of the Global On-Market Design Quality Engineering function.

-Implementation of a Global Risk Management Process compliant to ISO 14971:2019 & IVDR that elegantly facilitates execution & decision making in high innovation RUO/IVD applications.-Implementation of a Global Product Risk Management Software to enable efficiencies in risk management execution and interconnection to other elements of Illumina's QMS.-Leader of On-Market Design Quality Engineering function.

-Led Illumina’s Global Design Quality Engineering Organization of (30) employees responsible for strategy and execution of Design Control and Risk Management activities supporting a portfolio of between 20-30 RUO & IVD New Product Introduction (NPI) projects at any given time.-My team and I grew the organization from (10) to (30) employees in my tenure, (100%) to plan. -Led improvements that resulted in measureable increases to employee engagement across entire organization from an average of (52) to (78) out of (100), and in addition reduced unfavorable responses by (25) points on average.-Implemented ‘Project Levers’ to create a consistent means of aligning the priorities of senior leadership with the strategies of project teams.-Implemented ‘Product Development Process (PDP) Strategy Tool’ to guide project teams in selecting appropriate PDP strategies based on Project Levers.-Implemented ‘The Three-Legged Stool’ to improve collaboration and decision making on PDP strategies across Development, Project Management, and Quality functions.-Implemented ‘Product Development Process Bi-Monthly All Hands’ meeting for all new product development functions (average 100+ attendees) that brought project retrospectives and strategies to other teams. Held (12) meetings over a two-year period.

-Led a team of Engineers to redefine, develop, and grow Stryker Instruments' Data Management, Analytics, and Consumption capabilities around Product Quality and Non-conformances.-Process owner of Risk Management at Stryker Instruments.

Led a team of (7) Quality Engineers responsible for leading cross functional engineering teams to execute and present product field action assessments (HHE's) to senior leadership, ISO 14971 risk analysis, customer problem resolution, product improvement via the CAPA process, Service production engineering, and complaint trend analysis.

–Lead AQE on (9) separate Interventional Spine new product development projects at varying stages of development- including the 11Ga iVAS VCF system, Venom nerve ablation electrodes, and the 10Ga Curette.–Created, launched, and supported the first Post Market Complaint Data infrastructure for Business Unit breakdown of complaint metrics at Stryker Instruments - Kalamazoo.–Assisted in research, creation, and development of (8) ‘Design, Input, Output, Verification, and Validation’ forms and (8) Risk Management Files.–Planned Process Validation of (2) projects. Oversaw Process Validation execution of (2) projects.–Planned Design Verification and Validation of (2) projects.

–Led the development and implementation of the Current Product Improvement Team (CPIT) process. –Led the first Pilot CPIT team in Micro Surgical handpieces and root caused/corrected the 2nd highest complaint related failure within capital product for the site in 2011: Universal Driver - Worn Gears. –Assisted in the creation of the complaint trending systems used today by the Divisional Quality Engineering team to monitor failure mode per use rates and complaint rates for individual products.–Created the complaint trending systems used today for the roll up of individual product trend files into product families and manufacturing units.–Created the responsibilities of a new product launch Post Market Quality support initiative with the System 7 Launch. My execution was used as the model for S2 Drill and CD4 launches in 2012.–As the Quality Engineer lead for both Micro Surgical and Heavy Duty handpieces on the Post Market Performance team I travelled to numerous customer facilities to root cause and successfully correct issues that were causing higher complaint rates at those facilities and a negative customer experience.–Created complaint investigation templates and archives to increase complaint investigation efficiency and consistency between all members of my team while facilitating knowledge transfer between investigators. My archive was benchmarked by the Stryker Corporate Process Owner of complaints.–Investigated (2012) medical device complaints in my tenure. –Assisted Post Market Team in reducing open complaint investigations in 2011 from (6500) to (<2000).–Reduced the open population of open Heavy Duty complaint investigations aged over (50) days to less that 10% of the total open population in Q1 of 2012.

-Implemented, organized, and maintained a vital project related documentation database that streamlined project management of 500 ton LNG heat exchangers.-Oversaw design and implementation of maintenance walkways for LNG equipment.-Cooperated with customers and technicians regarding large scale shipping of completed LNG heat exchangers resulting in two unharmed and punctual deliveries to the Middle East and Africa.

-Developed assembly and maintenance manuals for high pressure (4000-10,000 psi) cryogenic liquid argon, helium, hydrogen, nitrogen, and oxygen pumps resulting in uniform maintenance and improved reliability for these pump models company wide.-Designed diverter valves for pressure vessel relief trees guaranteeing appropriate flow rates for a safe release in case of conditions for catastrophic failure.

-Analyzed high frequency pressure fluctuations occurring in turbine shrouds through implementation of sensitive instrumentation and testing resulting in lower alternating stresses in the machinery extending operating life and reliability.-Authored technical failure analysis reports and proposed solutions for customers regarding failed rotating equipment.-Created engineering drawings for improvements to rotating equipment that eased manufacturing, assembly, and maintenance difficulties and improved reliability.

-Planned and executed preventative and responsive maintenance of pumps and pressure vessels throughout a chemical facility resulting in minimal operational losses.-Specified and implemented an efficient and reliable Venturi evacuation system for vacuum jacketed heat exchangers to minimize heat loss resulting in a cost effective way to maintain dated equipment.