Luke Steele

Experience

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  Big Apple Bagel

  Feb 1996 - Jul 2003

  Assistant Manager

  *Count down the registers and the end of the night deposit.*Take inventory reports including end of the month, merchandise, and weekly inventories.*Figure end of the week paperwork.*Figure payroll for the employees.*Figure the store revenue, budget, and man-hours.*Create the schedule for employees.*Responsible for setting up crew meetings and crew rap sessions.

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  Borgess Health Alliance, Inc.

  Jul 2003 - Jan 2006

  *Develop PeopleSoft Functionality Navigation to run specialized reports.*Develop automated processes for PeopleSoft 8.8 HRMS. ~Automated Pharmacy and GiftShop Transaction Load for Payroll. ~Automated paper-system Short Term Disabilities Project. ~Help automate 403B Employer Matching Program. ~Help automate Non-Employee Database. ~Help automate Past Employee History Database (Interpers). ~Automated several different Flat File Loads.*Run Daily Benefit Administration Event Maintenance for 11 Benefit Programs.*Help Process and Run Open Enrollment Annually.*Help Payroll with Year-End Data Loads, W-2 Processing, and W-2 Print.*Received 2nd Service Excellence Award in January 2005. Show less

  • Application Analyst

    Jan 2005 - Jan 2006

  • Human Resources Information Systems Assistant

    Jul 2003 - Jan 2005
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  Ascension

  Jan 2006 - Oct 2009

  *Upgraded 5 databases that were PeopleSoft 8.8 HRMS/PeopleTools 8.42 to PeopleSoft 8.8 SP. 1 HRMS/PeopleTools 8.48.*Upgraded 3 databases that were PeopleSoft 8.8 FCM/PeopleTools 8.44 to PeopleSoft 8.8 FCM/PeopleTools 8.48.*Develop automated processes for PeopleSoft 8.8 SP. 1 HRMS. ~Created Manager Self Service e-product. ~Created Employee Self Service e-product. ~Created Physician Recruitment e-product. ~Created 403B/Pension Interface for two vendors. ~Re-wrote 403B process with employer match contribution. ~Front-loaded two new companies into PeopleSoft HRMS databases.*Taught Advanced Query Tool classes on a national level to A.H.I.S.*Apply federal tax updates to PeopleSoft 8.8 SP. 1 HRMS databases.*Implemented Position Management.*Database administration work on all PeopleSoft HRMS and FCM databases. Show less

  • Solutions Development Senior Analyst

    Jun 2007 - Oct 2009

  • System Analyst

    Jan 2006 - Jun 2007
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  Stryker

  Oct 2009 - now

  *Became Build Lead Senior Manager for TrackWise, LabVantage, and Medidata.*Leading a team of developers for LabVantage.*Upgraded the Global Instance of TrackWise from 9.4.3 to 10.7.1, moved the Oracle Instance from 12c to 19c, and decommissioned old footprint of TrackWise out of old data center.*Delivered Managed Release R25.*Provided Regression Testing support for the DIWS and DOWS integrations to SAP for Accelerate Waves R6 and start of R7.*Led efforts to move LabVantage infrastructure between two data centers.*Launched a division live within LabVantage for 2 Micro-Biology and 2 Chemistry labs.*Leading build efforts to launch remaining 3 labs for 2 divisions on LabVantage for LIMS and decommission the old legacy iLab system.*Leading build efforts to integrate a third division into Medidata for Clinical Trials. Show less *Designed, Developed, and Launched the Product Security (PS) Module in TrackWise.*Designed and Collaborated with MiddleWare to move the UDI Interface from BizTalk to MuleSoft.*Began moving the Global Instance of TrackWise to Microsoft Azure Cloud.*Collaborated with Sparta Systems on SETID override within eReporting Tool for MDR requirement.*Delivered Managed Releases R20 - R24.*Provided Regression Testing support for the DIWS and DOWS integrations to SAP for Accelerate Waves S4, R5, and start of R6.*Acquired LabVantage (LIMS) as a system to support within the RAQAC umbrella. ~Provided architectural support. ~Collaborated with developer to install SSL Certificates on Application Servers. ~Collaborated with developer to resolve log4j security vulnerabilities. ~Began leading efforts to launch 4 labs within LabVantage.*Delivered Medidata Release 3 for Hypercare stability of the system. Show less *Inherited Medidata (Project SWIFT) and LIMS from staff turn-over with no prior experience or knowledge of the Software or the business process and self-taught how to use Medidata and navigate through Medidata to process ambiguity and learn about the business process of Clinical Trials.*Provided support for SWIFT R1 after launch.*Delivered SWIFT R1.5 which provided TSDV and Randomization Capabilities within Medidata.*Delivered SWIFT R2 which provide CTMS, eTMF, Payments, and Global Library Capabilities within Medidata.*Mentored Vivek Godiyal on TrackWise System Installation Process.*Mentored Chuck Kourtjian over 5 years to help him expand his career.*Provided Collaboration and Support for new Operating Model within IT that broke out the TrackWise Team into the Business Partner, Build, and Run Towers.*Presented a TrackWise Overview and TrackWise Demo to Alan Douville (CIO) to inform him on TrackWise Capabilities.*Presented an EU MDR Deep Dive Functional Review to Bijoy Sagar (CIO) to inform him of current TrackWise Projects and support of EUDAMED.*Presented a TrackWise Overview Functional Review to Malti George to inform her of TrackWise Capabilities.*Presented an IT Run / Support Overview for SWIFT to Jody Powell at a SWIFT Strategy Meeting.*Participated in the Virtual Development Academy (VDA) Pilot Group which lasted a year and has officially launched for Stryker.*Member of the IS Kzoo Fun Group which planned and hosted several events for local Kalamazoo IT Employees such as 501s, Holiday Parties, Annual Chili Cook Off, and Birthday Gifts.*Member of the Corporate Events Committee which planned and hosted full corporate events such as Bring Your Child to Work Day, Employee Appreciation Week, and Gull Meadow Farms Evening.*Member of the Stryker Strive Well Being Champions to promote Virgin Pulse and Group Activities of Stryker Strive.*Member of the 2022 ITLM Planning Committee to represent the Build Tower for Malti and plan a fun evening event. Show less *Provided FDA Compliance changes for MDR to bring the MDR Schema in line with the MIR Schema using the IMDRF Codes.*Built the MIR 7.2 XSD Schema off the MIR 7.0 XSD Schema as Sparta was not going to deliver the XSD Schema in time for the new EU Submission Schema.*The MIR 7.2 XSD Schema I built was leveraged by MiddleWare to make it compatible with the 7.2 MIR PDF Load Process for EU Submissions.*Delivered Managed Releases R12 – R19.*Collaborated with MiddleWare to retire TrackWise BizTalk Interfaces and transfer them to MuleSoft Integrations with the Dynamic Inbound Web Service (DIWS).*Collaborated with MiddleWare to move the MDV process to the MIR process using the previous MuleSoft Technologies but new MIR Schemas.*Collaborated with Security to establish SecureOne on TrackWise Servers and get a service account up a running to keep system automated processes running.*Provided Regression Testing support for the DIWS and DOWS integrations to SAP for Accelerate Waves R1.5, R2, R3, R4, and start of R5.*Collaborated with the OnePLM Team to regression test UDI for a successful launch of R2D2.*Continued running the TrackWise Disaster Recovery Testing Process with successful transition to the Run Tower. Show less *Upgraded the Global Instance of TrackWise from 8.7.10 to 9.3.0 to 9.3.4 to 9.4.3.*Upgraded the TrackWise ETL from 2.0.1 to 2.2.*Brought the TrackWise Footprint into SSL Certificates and had all servers pass security scans with no vulnerabilities.*Found a memory leak in TrackWise 9.3 Web Services and provided information to Sparta that was later fixed in a point release.*Figured out a Crystal Report DDL Runtime Issue that would cause Crystal to Crash every few days in TrackWise 9.3 and provided solution to Sparta which was then corrected in later releases of TrackWise 9.4.*Provided support to bring TrackWise Oracle 11g Databases to 12c during 9.3 upgrade.*Built and Launched in Production the TrackWise MIR MDV EU MDR Project which transitioned MDV’s into MIR’s to meet the EU Regulations of MIR submissions and MDV retirement.*Built and Launched in Production the TrackWise Medical Device Single Audit Program (MDSAP) which enhanced the AER creation process to streamline workflow within CHS through the use of Reportability Trees for each country.*Built and Launched in Production the TrackWise Risk Management Project that streamlined Health Risk and Compliance Assessments and brought the Fast Track CAPA into TrackWise through the #makeCAPACool initiative. Show less *Upgraded the Global Instance of TrackWise from 8.4.11 to 8.7.10 into PURE storage.*Upgraded the eReporting Tool for eMDR/eMDV/UDI from 2.1 to 2.3 then MDR to 2.5 for FDA R2 Regulations.*Participated in TrackWise 9.0 BETA Program.*Built Global Supplier Audit Mananagement 2.0.*Built Global TrackWise Access Request removing 35% of TrackWise Help Desk Tickets.*Built Global Commercial Hold.*Built Global Product Field Action.*Built Global Drug Safety Enablement Submissions and provided iCSR submissions to the FDA.*Built Global AUDIT Module to provided Corporate, Internal, and External Audits using the Audit Execution Package.*Built Global SAM Information Audit Manager.*Collaborated with Workday to retire HRMS Feed.*Converted TrackWise Change Controls to the IS Managed Release process and delivered releases R0 – R11.*Moved Legacy TrackWise to View Only.*Created the 8.7.10 Reporting Database Materialized Views.*Designed, Developed, and Created the TrackWise Disaster Recovery Plan.*Designed, Developed, and Created the Dynamic Inbound Web Service (DIWS) for an integration to SAP for NCs and Commercial Holds.*Designed, Developed, and Created the Dynamic Outbound Web Service (DOWS) for an integration to SAP for NCs.*Designed, Developed, and Launched Web Services that provided Grid Copying, Effectiveness Check Logic, and Calculations.*Provided support to submit 21,000 submissions for the UDI Wave 2015, 2016.*Provided Vendor fixes that were qualified to repair broken snapshots.*Mentored 2 junior employees.*Obtained Lean Practitioner Green Belt Certification by revamping the eMDR/eMDV Acknowledgement Process for Lean Six Sigma. The solution provided $112k USD of annualized savings with a lead time reduction from 5.37 days to 1.05 days.*Received the 2016 “Living the Brand” Award at the IS 2017 Leadership Meeting.*Received the GQO Beth Staube Quality First Platinum Award from RAQA.*Presented at the first L3 Functional Review to Ernie and his direct reports. Show less *Upgraded the TrackWise Database from 10g to 11g.*Upgraded the Global Instance of TrackWise from 8.2.3 to 8.3.4 to 8.4.5 to 8.4.11.*Upgraded the eReporting Tool for eMDR/eMDV/UDI from 8.4.5 to 2.1.*Keep the Sandbox Instance of TrackWise on its most current version (8.7.7).*Help Design, Write, and Build Web Service Integrations for eCAPA, CHS, and SAM.*Help Design, Write, and Build MiddleWare Integrations between MDM and TrackWise.*Built the Global TrackWise UDI Submission Tool (TrUST) Module.*Built the Global TrackWise Access Request (TAR) prototype.*Built the Global SAM 2.0 prototype.*Presented the Benefits of using the eReporting Platforms and the Global TrackWise User Conference in 2015 for eMDR/eMDV/UDI. Show less *Provided assistance for the FDA by submitting 2000 UDI and 2000 MDR records to stress test the ESG with the launch of the GUDID.*Designed and Developed CHS 2.0.*Provided SQL commands to BI for the ETL Encompass Integration.*Created the Design Specification Crystal Report for validation documentation.*Mentored and Developed 2 Junior System Administrators for TrackWise.*Provided assistance with the Corporate and ISO Audits and how Change Control is followed for TrackWise.*Participated and gave guidance in several Design Review Meetings of new modules or major upgrades to existing modules within TrackWise. Show less *Designed, Developed, & Launched the Field Account Contact Solution (FACS) module.*Created a Full TrackWise Configuration Crystal Report that became the Design Specification Document for IT Project Methodology.*Created a Dynamic As Viewed Record Layout Report to eliminate 10 Individual As Viewed Reports which later was used in the Global Instance of TrackWise.*Designed the Global Instance of TrackWise Infrastructure Footprint which consisted of Production, Staging, Development, Training 2, Training 1, and 4 Sandbox Environments.*Built the Global Nonconformance and CAPA (eCAPA) Module.*Built the Global Complaint Handling System (CHS) Module.*Built the Global Post Market Health Risk Assessment (ePMHRA) Module.*Built the Global Supplier Audit Management (SAM) Module*Built the Global Product Hold prototype.*Built the Global Product Field Action prototype.*Built the TrackWise Issue/Change Request (TICR) prototype.*Participated in the Sparta System Focus Group for Reporting which later became TrackWise QualityView (Analytics).*Developed a Broken Snapshot fix for the Vendor Sparta Systems which the vendor validated that kept the CHS Project on its aggressive timeline and eliminated 3 weeks’ worth of lost work. Show less *Maintain, modify, and update existing TrackWise configurations of Nonconformance and CAPA’s while updating design documentations to keep TrackWise in a validated state.*Created prototypes of DHR and SYSCO workflows within TrackWise.*Built automated process around the Selection Value Import for TrackWise.*Built database scripts for Training Account Loads and Database Restores.*Upgraded 7.0.5.11 TrackWise environment to 8.2.1 Version.*Created a SharePoint Applications Portal Launch Screen. Show less

  • IT Sr. Manager, RAQA Systems

    Jul 2023 - now

  • IT Senior Solution Architect, RAQAC

    May 2022 - Jul 2023

  • IT Solution Architect, RAQAC

    Jan 2022 - May 2022

  • IT Solution Architect, TrackWise

    Nov 2020 - Jan 2022

  • IS Solution Architect, TrackWise

    Mar 2019 - Nov 2020

  • IS Senior Technical Lead

    Mar 2015 - Mar 2019

  • IS Technical Lead

    Mar 2014 - Mar 2015

  • Lead System Administrator

    Mar 2013 - Mar 2014

  • Senior System Administrator

    Mar 2011 - Mar 2013

  • System Administrator

    Oct 2009 - Mar 2011