•Created over 100 Instructions for Use (IFU’s) from inception through completion in the Windchill Product Lifecycle Management System for the Depuy’s EU MDR Remediation Project.•Worked collaboratively with Project Managers, Directors, Quality, Regulatory, Packaging, Medical Affairs, Sterility, Product Development, Engineering, and External Suppliers/Print Houses to ensure successful completion of IFU’s.•Managed production and translations of IFU's and manuals, including layout and translation quotes (through Global Translation Center), proofreading, and acceptance of final IFU's.•Loaded Electronic Instructions for Use (eIFU's) into Veeva Vault/Index for acceptance and publishing.•Responsible for contacting external suppliers and print houses for necessary documents for successful project completion.

•Led cross-functional teams to ensure that deadlines were met, and that the project deliverables met respective government requirements for Navistar Defense and Navistar Corporation.•Created, documented, and managed bill of materials used in the manufacturing and support of products.•Initiated, revised and updated Unigraphics NX drawings for accuracy, standards, and specifications required.•Served as the primary contact for the customer on matters pertaining to the program.•Leader who is collaborative and can adhere to project best practices.

•Assisted Core Team Leaders and Site Program Manager in coordinating, planning, and executing project meetings both internal and external for company-wide major FDA/EU MDR remediation program.•Worked closely with medical doctors, medical writers, and all levels within the organization.•Facilitated cross-functional team meetings, effectively tracked project timelines, identified risks, opportunities, and any issues so to develop resolutions to meet quality and timeline goals and objectives.•Analyzed project schedule and prepared regular status reports for the Core Team, Extended Team, and Site Program Manager.•Worked with IT department on best way to improve our processes and ways of doing items more efficiently.•Utilized WebEx for scheduling, as well as facilitating meetings through reviewing of SharePoint dashboards.•Obtained documents via the organization’s database, which were posted to SharePoint.

Provided assistance to facilitate efficient execution in a cross-functional core/project team by partnering with the Workstream leads and team members in project planning, execution, monitoring, reporting, and documentation.•Provided support to site Program Manager in managing and executing company-wide major FDA/EU MDR remediation program.•Interacted regularly with the IT department on process improvements and efficiency measures.•Tracked project risks, opportunities, and issues to develop resolutions to meet quality and timeline goals and objectives.•Assisted in monitoring and improving project planning elements for various projects under remediation. •Created, managed, and documented dashboards for various projects in SharePoint.•Collaborated with Project Managers (Workstream leads) in managing project schedules, manpower allocations, and overall workstream communication.•Assisted Core Team Leaders and Site Program Manager in coordinating, planning, and executing project meetings both internal and external. •Maintained internal documentation, including updates to project schedules, notes, and revenue tracking in Excel.

•Wrote Capital Expenditure Proposals for Albion’s five plants in amounts ranging from $3,000 to $3.5 million dollars in total cost.•Assembled, compiled, and reconciled pro forma statements and Profit and Loss statements for specific periods of time.•Interacted closely with Engineering, Quality, Plant Supervisors, Plant Superintendents, Plant Manager, and Vice President of Component Operations to ensure pricing of components and parts were correct.•Important part of a team assembled for the company wide purpose of getting the corporation to implement a standard costing system which would realize the company’s true costs of direct labor, direct material, and manufacturing overhead.•Completed special projects assigned by the Engineering Manager and the Vice President of Component Operations.

•Processed temporary work orders during the Launch Process for the GM 2014 MY Sierra and Silverado.•Coordinated the activities of the Plant Sequencer, Parts Suppliers, Engineering, Plant Reliability, and the Material Department in the processing of temporary work orders.•Coordinated with Supplier/Supplier Quality/Design Engineers to ensure parts are being shipped to the Plant Sequencer in time for the next build.•Coordinated with Plant Sequencer to ensure parts are sent to the appropriate quarantine area and documented on log sheets.•Reconciled the TWO Master List against lists generated by Engineering.•Ensured parts received are correct for the specific build event. •Reconciled Plant Sequencer Log Sheet against the Bill of Material.•Conducted daily meetings with plant and corporate personnel as to the status of the launch.

Coordinated management of Global IT project (with operating budget of $9M) directed toward signficantly reducing product complexity, improving design, release time, bill of material accuracy, and the overall user interface.•Reduced errors and improved first time coding by over 50%, and increased bill of material accuracy by 75% in 6 months timeframe.•Project would increase repeat sales, while improving customer service; and result in $10M+ / year savings realized with implementation of new system.

Integrated customer requests for improved service industry demands, and overall product management of severe service truck product line.•Created and developed production option lists/master model indexes, for multiple truck models and multiple engineering base projects, served as project summation and leading to greater business efficiency.•Reviewed and approved customer special requests and new feature code requests for product line, allowing organization to know features and items approved for each respective program.

Implemented product structure/bill of material processes using release integrity group software systems and tools to create, document, and manage bills of material used in manufacturing and support of products. Department lead for major programs, coordinating with program teams, requirements and advising cross-functional groups about product structure. Evaluated engineering release work for correctness and quality, and conducted truck orders testing, closely coordinating changes with production plants.•Worked with 4 diverse groups of engineering – adapted communication style to learn and engage, reduced release timing while effectively meeting customer needs.•Process Development lead on cross-functional team for 1ST ever successful completion of Go Fast Program, showing time to complete program can be reduced by 25-40%, when teamwork and educated risks are fully utilized.•Used leadership, communication, and interpersonal skills to direct engineering teams to over a 95% on time release rate in under two years.•Served as a liaison between IT,Engineering, Accounting, Quality, and the production plants in order to complete engineering releases early or on time.•Proven ability to interact and work with different levels of the organization, by providing the necessary strategic guidance in product development and program processes.

Supervised, trained, coached, and evaluated 100+ employees in union environment. Proposed, administered, and allocated budgets, and monitored and maintained product inventories and shrink levels. Developed and implemented sales plans to meet and exceed objectives.•Reduced store and back room inventories by over 30%; achieved $3M in annual savings through negotiation of items while ensuring continuation of customers’ product preferences.•Conducted and implemented employee training, development,scheduling,mentoring, and peformance reviews of all store employees.

Engaged vendors and initiated purchase orders per customer requests and requirements; interpreted design changes with engineering, marketing, sales, and management to achieve optimal procurement results. Updated procurement records, cost information and pricing of materials, delivery performance, and product quality records. Invoiced Ford Motor Company, DaimlerChrysler, Isuzu, and other vendors for tooling monies.•Orchestrated new and innovative production and manufacturing measures to reduce production material costs by 15%, representing annual cost savings of $2M. •Collected over $25M in accounts receivables and design changes due from vendors.•Updated regularly, the procurement records, cost information and pricing of all axles, delivery performance, and product quality records in Excel.•Worked with quality groups to ensure PPAP requirements were completed, and served as key customer service contact which cultivated solid long -term relationships.•Interpreted design changes with engineering, marketing, sales, and management in order to develop the best course of action while achieving optimal results.•A key member of a team that participated in vendor selection and negotiation, while carefully keeping in consideration, the overall company objectives.•Conducted monthly presentations and reports on how invoicing for tooling and accounts receivables collections were progressing.•Invoiced over $100M in tooling during a three- year period.•Processed cost estimates, engineering change requests, protype and blanket orders, and assisted with engineer deviation requests.