Wendy Kennedy Email and Phone Number

Move the prototype devices to full fledged commercialized devices. Ensure FDA standards are followed. Ensure devices are manufactured internally or with Contract Manufacturer. Built QMS from scratch.

During my tenure I managed and actively participated in the following:Hardwareo Managed R&D Proof of Concepts for hardware device updateso Making controller board changes for upgrades & supply chain issueso Redesign of HDLC with Design Control and move into production environment● Softwareo Managed R&D Proof of Concepts for software updates all lines of businesso Redesign of SDLC with Design Control and move into production environmento Implementing projects to design release mgmt. practices to follow Design control (CI/CD)o Redesign of Agile Practiceso Teaching Product Managers & Product owners Agile Methodologies▪ Redesign refinement of requirements▪ Architecture reviews/Designs▪ Updates to handing off to Operations for commercialization▪ Formalized designing work intake process into software Corrected processes surrounding Sprint Management▪▪ Defect Management during testingo Redesign of HDLC with Design Control and move into production environment● Softwareo Managed R&D Proof of Concepts for software updates all lines of businesso Redesign of SDLC with Design Control and move into production environmento Implementing projects to design release mgmt. practices to follow Design control (CI/CD)o Redesign of Agile Practices▪ Architecture reviews/DesignsQuality/Regulatoryo Auditso Managed audits to successful completiono ALCOA+ / InfoSec / Pen Testo ISO 13485 / 14971o Implemented new standard to align audit questions to SHS product lines that streamline the audit processRegulatoryo MDD to MDR (Class 1 to Class 2a change)o Gap Analysis of current stateo Project plan phase 1 for attaining Transitional Provisionso Phase 2 applying for MDR Certificationo Country specific regulatory assessments and risk (other EU, Israel, China, Asia, Australia)o Moved from a manual / computer assisted to a certified ISO 13485 eQMS solutiono Taught Design Control • Complianceo ISO 27001/2 Implementation

● Portfolio Manager (Security, Infrastructure, Data Privacy) o Network redesigns and upgrades o Assisted in the build CMDB (scanning and documenting infrastructure)o Migrated from onsite hosted to cloud infrastructure (SAP, Product (iTero), Overall Applications) o Oversaw the Data Privacy projects dealing with GDPR, Russia Law, Netherlands, China, Brazil, Vietnamo Directed the Information Security projects pertaining to SOC2, Cybersecurity SOC (Logging and Monitoring / Splunk), Application Security (SAST, DAST), Multifactor Authentication (Internal Employees and External Customers) ● Global Release Management o Redesigned process to a formalized, repeatable, and structured approacho Analyzed technical dependencies across applications and systems to ensure compliance to architectural designs and confirm flow for end to end system integrationo Aligned regional and global work for a consistent implementation strategy● Environment Management o Provided consistent communication on the status and availability of environments, which did not exist previouslyo Aligned the environment availability with the project timeline to convey a succinct view into the implementation calendar o Managed the environmental gates for projects and coordinated with operations as projects requested entry into a planned release ● Architecture Review Board (ARB) o Orchestrated the weekly ARB meeting as a board and voting member o Assisted teams with their presentations to move them through the review o Tracked the results of each meeting and provided guidance to those that were denied or have action items assigned to their project● Technical Risk Assessment Owner ● Advised and managed implementation and processes behind the PMO tool (Planview) ● Provided input and corrective actions stemming from audit points to correct our PMO SOPs ● Directed the Agile implementation and adoption ● Managed the digital business transformation:

● Reported directly to executive board, mission was transformation to cloud platform for all products globally. Rebuilt 4 person engineering team to 100 engineers and Quality Management specialists globally. ● Lead and advise technical personnel involved in development of cloud based platform (SaaS) and any other new software or hardware integrations.(LAMP Stack on AWS using S3. JIRA, JAMA and TFS depending on office)● Advise & collaborate with executive staff in software integration with UltraLinq internal products and other external products for global strategy.● Assisted Regulatory team in creation of the Quality Management System (QMS), FDA 510K, ISO 13485, 27001, GDPR & MTSC. Received ISO auditor certificate.● Created overall strategy for core product along with integrated roadmaps for the rest of the portfolio.● Built and lead staff in creation of SDLC & Product LifeCycle processes to support the QMS.● Trained technical project managers, help desk and product managers on their roles and expectations for deliverables.● Create and manage budget for software development & QA teams.● Built internal leadership training to grow personnel for business continuity and succession planning.Extra Activities● Invited to Speak at the American Medical Device Conference in Chicago, IL 2017 on “Transformation in the Industry. How do we do things faster in a highly regulated industry”

● Managed application of trading system to store all trades for global use with a dispersed team in multiple countries. (Java, NoSQL (MarkLogic), Linux RHEL,Apache Storm, Kafka)● Removed management overhead from development team to make way for agile methodology and free team up to take ownership of product.● Revamped functional testing to embed testers into the development team to regain time in the schedule.● Redesigned release management to properly assess risk of code moving into production environment and reduce constant churn of the environment.● Aligned the Load & Performance (LnP) work to determine stability and scalability in the production environment which was nonexistent. ● Designed an intake process to better on board work into the team for size and then scheduling.● Created a change advisory board to manage extra work brought into a release to better assess viability and risk to current ongoing work.● Collaborated with Architecture and Product Owner to ensure the trading platform kept to the overarching principles of the product while working with consumers to meet their needs.● Identified leaders in the development group to assist in reinforcing agile methodology and help teams to push forward to increase overall velocity. This allowed me to groom up and coming leaders for the organization. Extra Activities● Represented Deutsche Bank with the College of Computer Science with North Carolina State University. Managed the senior project program.● Co-Chair of the Woman on Wall Street Employee Group for the Cary Technology Center.● Mentor in the Employee Mentoring initiative.

Director of Quality Assurance for Financial Institution Technology Group• Manage a blended team of on shore and off shore test engineers for the core money movement applications (4.6 Trillion dollars) across all lines of business. • Built the team from scratch (on & off shore), created an environment of learning and proper risk taking to achieve a high performing group able to address the complex issues of the business.• Created succession plan to have the ability to provide growth opportunities to staff without losing knowledge in the team.• Collaborate with development, core product owner and business product owners to create a vision for the overall product.• Manage the portfolio/budget for both departments within my team.• Introduced QA process into the group such as run rate execution plans, end to end testing, project management for integrated testing with multiple QA groups and proper vendor QA integration into a project testing plan.• Created metrics & milestone dashboards to monitor QA progress with data.• Developed a test lead in each area (US & India) to assist in leading the group and developing up and coming management talent.• Promoted release management processes within the group and with our development partners. Extra Activities• Steering Committee member of the Women in Technology Special Interest Group (WITSIG) in NC.• Facilitated a “town hall” type panel discussion for WITSIG event with multiple level leaders from NC.• Member of the Women’s Networking Group and Chairman of the Events and Logistics committee (WNG).• Participated as a Mentee in the inaugural, NC WNG mentoring program in 2012.• Participated as a Mentor in the inaugural FI Mentoring program in 2013.

Quality/Test Manager for IS Business Applications• Manage a blended team of 25 test specialists for the Sales & Marketing, Finance and Web Office applications who are responsible for the manual and automated testing of the software. • Collaborate with the User Acceptance Testing group to ensure process is well defined for all new software releases with the above mentioned areas.• Manage the Software Configuration team for all code within the development area.• A member of the IS Business Application Improvement work group that reviews the quality standards of the products and the processes within development and test teams.• A member of the process improvement initiative group to redefine our fulfillment process for all written communications to our external customers.• A lead member of the Quality Lean initiative in the test department to consistently look at our testing processes to ensure quality at all times into our production environment.• Member of the steering committee to plan introduction of Agile into departments and ensure process was being upheld and mediate any issues.• Member of the Business Requirement Workgroup that redefined the business elicitation Extra Activities• Coordinated, developed and facilitated week long training for 100 people in basic testing practices.• Facilitated and designed Project Management training for PMO.• Facilitated and designed leadership training for PMO leadership staff.• Created mentoring program for technologists.

BCBSNC is a non-profit insurance company that services 3.5 million customers Senior Release/Product Manager for Enterprise Project OfficeManage corporate projects(Internal or Federal Mandates) connected to core systemsDeveloped new release management processes that decreased project slippage by 40%Re-Tooled release management to deliver higher value to internal customers by training team to risk assess projects, tighter coordination between Business, Development and Testing groups, developing swift escalation process and empowering team to make decisionsGo to person for troubled programs and or projects to get them back on track and deliver on timeCoordinate strategic development of new project office and project management trainingCreated shadow program to train project managers in release management

Own/Manage the core systems management software across platforms and hardware systems globally, Manage the Development, Test, User Acceptance test and Project Management teams globally. Organize Executive, Sales, Marketing , Development and Customer input for all content. Manage the complete lifecycle of the product to general availability and public announcement. Create and Maintain all outside vendor relationshipsDesign new process to handle all internal and external dependencies to create synergy between all teams. Coordinated LEAN/Agile initiative for System Technology Group for US division.

Decision checkpoint on content for each customer release & customization. Manage all builds and releases globally for SW Development, NRSC SW and Level 3 Support Team. Created execution meeting for cross functional teams to communicate on common projects. Manage/Maintain all code for Self Checkout project (52 separate coding streams). Organized the conversion of code from Visual SourceSafe to CMVC by organizing a mutli-departmental team. Redesigned build process for new library system. Directed team in making all changes. Consult for SW Development, NRSC, Support, Engagement managers, Training and Sales for all Self Checkout projects. Consult for Rochester, MN manufacturing plant on Self Checkout. Redesigned the SW release process to the manufacturing plant which in turn saved 2 Fulltime employee of expense and reduced software errors in the plant by 85%

Responsible for software content & customization that was done for each client. Managed personnel and all project deliverables for software development department. Managed and maintained all builds of executables for automated self checkout project. Created build process and documentation of software for development staff. Collaborated in the process of internationalization of the self checkout product. Created all test software and release documentation for quality assurance (QA) staff. Created policies for software releases into manufacturing facility and the field. Organized and managed all customer specific files through Visual Source Safe and detailed processes and policy. Created testing scenarios for new products and features. Collaborated in the development of new features for the self checkout product with Hardware and software teams

Self Checkout Business - PSIResponsible for software content & customization that was done for each clientManaged personnel and all project deliverables for software development departmentManaged and maintained all builds of executables for automated self checkout projectCreated build process and documentation of software for development staffCollaborated in the process of internationalization of the self checkout productCreated all test software and release documentation for quality assurance (QA) staffCreated policies for software releases into manufacturing facility and the fieldOrganized and managed all customer specific files through Visual Source Safe and detailed processes and policyCreated testing scenarios for new products and featuresCollaborated in the development of new features for the self checkout product with Hardware and software teams; One of the world's largest suppliers of medical products and software to the Healthcare Industry. Developed one of the first Graphical User Interface healthcare systems running on a Microsoft platform. Purchased by SMS in 2000.

Decision maker on software content for each new release along with Marketing ManagerDirected all software releases for the service/support department including the control when the product was ready to be distributed. Tracked the progress of releases or fixes through Quality Assurance (QA), made sure compact disks were cut properly, new instructions were printed, QA'd install wizard in all environments, upkeep of enhancement database and trained employees and customers on new releasesManaged the implementation of software for assigned clients including process redesign of offices, hardware evaluation, super-user training, building of customer databases, tracking/resolution of all issues, and go live supportImproved the implementation guidelines concerning new installations for the project managers.Trained implementation staff on breaking healthcare issues, proper implementation guidelines and medical office proceduresRestructured help desk procedures for new client implementations and software beta test sites.Directed phone support for field personnel for go lives and upgrades.Supervised the channel services which included go live support for their clients/personnel and in-house training for SMS employeesSpecialty Care Network (SCN; Private physician Management Company for orthopedic physicians. Contracted with 50 clinics nationwide providing the strength of a dedicated and knowledgeable IT staff without the burden of additional office personnel.

Responsible for managing 25-member conversion/testing teamImplemented Billing and Accounts Receivable, Scheduling and Security modules in IDGenerated all Database Management Systems (DBMS) reports for use by Chief Financial Officer and Billing Director for 110-physician practiceInstalled and Maintained Wide Area Network (WAN) for central site and 60 remote sitesAssisted in Local Area Network (LAN) management, including training and support of corporate and remote end users on software and hardwareDesigned quality assurance testing scenarios for equipment and softwareResponsible for managing 25-member conversion/testing teamManaged Care CoordinatorOrganized HMO and PPO contract information for dissemination to group offices, resulting in better identification of patient insurance informationActed as liaison between 30+ managed care plans and physician office personnel for 110-physiaian groupRestructured and maintained all credentialing processes using National Committee for Quality Assurance (NCQA) guidelines by automated processes

Managed multiple project teams nationwideDirected the installation of all hardware and software in the corporate office and all nationwide sites.Handled the initial business and work flow analysis for all new clientsImplemented, built, and designed database tables in Billing and Accounts Receivable, Scheduling and Security modules of IDXGenerated all ad hoc reporting in the Database Management System (DBMS) for the practices and corporate officeSupervised all Quality Assurance on software and hardware testingStreamlined workflow in front and back offices for the practices and the corporate office helpdesk to increase productivity and client satisfaction; Private Management Company for multiple specialty physicians. Leveraged the size of the group to gain better insurance contracts and the use of a software system where information was transferable to all physicians.