Job Title: Sr. Project Engineer
Job Code: GW-01132115431463
Salary Range: DOE
Job Location: SC--
City: Sumter    State: SC
JOB SUMMARY: Reporting directly to the Senior Engineering Manager this position will manage various projects throughout the plant as assigned while upholding all aspects of Safety, Quality, Delivery, and Cost. Project focus will include both capital and expense projects as well as non-monetary project leadership in areas such as Safety, Focused Improvement, Quality, Productivity / Cost to Win, and Industrial Engineering analysis. Position will apply professional project management and validation practices to ensure that all projects are properly budgeted, planned, scoped, communicated, and executed in a manner that ensures an on time and under budget completion that meets all defined key deliverables. This senior level position will mentor and teach other engineers and plant administration in project management and will maintain the plant’s associated project management procedures and templates. ESSENTIAL FUNCTIONS: 1. Ensures that all associates, vendors, and contractors working on projects understand and comply with all safety and environmental rules and regulations so as to drive continuous improvement in injury reduction and regulatory compliance. Actively participates in EHS activities to lead and engage with the safety process to help the plant drive excellence in safety. Ensures that all projects follow plant, corporate, and regulatory safety and environmental rules and regulations. 2. Ensures that all projects strictly follow all Quality and validation procedures to properly support the plant Quality Management Process in order to remain compliant with ISO 13485 / FDA regulatory compliance for Medical Devices. 3. Assists the plant Engineering Managers with 3-5 year capital planning, budgeting, and forecasting. Actively manages project spend timing, forecasting, assets placed in service, and budgeting for his/her project assignments. 4. Assists Business Units with strategic planning, goal setting, and execution in alignment with the plant’s overall strategic plan cascaded down from the senior engineering manager and plant leadership team. 5. Develops the necessary design specifications (URS) and Statements of Work (SOW) for project based capital or expensed equipment purchases while following all corporate GRC purchasing guidelines and procedures. 6. Prepares cost estimates for the capital equipment, facilities, related expenses, and where appropriate, submits capital appropriation request for the projects and monitors the expenditure throughout the project cycle time. 7. Proactively researches, develops and designs new technology, automation, and other advancements that will drive lower manufacturing costs, better quality, or safer operations that enable the highest customer experience. 8. Ensures that effective project management discipline is adhered to by BD associates and third party contractors to deliver projects on time, accurate, and under budget. Ensures that scope and closure agreements are executed, well defined and adhered to while initiating scope deviation authorizations for any changes. Manage capital equipment, mold, and automation projects from concept through implementation and follow good project management process to ensure that all performance specifications and project objectives are met on schedule and on budget. Define project scope, determine required resources, and apply engineering and manufacturing process knowledge to develop User Requirement Specifications (URS), technical specifications, drawings, and bid documents (including mechanical performance requirements, automation and controls requirements or design, software and hardware requirements). Prepare capital appropriations requests including analysis of existing operations, estimation of project costs, justification of proposed actions including financial modeling, and consideration of alternative actions. Prepare purchase documents and ensure needed contracts are issued. Provide system start-up services and develop and validate the process. Track and report project expenses. Manage vendors to ensure systems meet specifications. Collaborate with quality engineering to establish and execute equipment acceptance and validation protocols. Periodically report on project progress, (usually monthly via 4 Block template). 9. Ensures prompt communication and follow up with manufacturing leaders any time there is a plant support system failure or related concern. Directs and facilitates DMAIC problem resolutions to make certain that problems do not repeat and cause unplanned downtime events. 10. Use engineering and technical knowledge to improve plant operations and manufacturing processes through capital and non- capital projects. Accurately and efficiently writes CB2’s, (capital authorizations), for assigned capital needs and mentors junior engineers in the capital writing process. 11. Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations. Support production and process upsets, troubleshoot production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations. 12. Provide technical expertise and support for equipment maintenance and troubleshooting. Work with operations and CI departments to develop preventative maintenance plans for new processes and machines. Identify and implement modifications to production equipment and processes to improve overall equipment efficiency (OEE) by improving process yield, improving production rate, and improving machine availability. Documents changes via the change control process. 13. Gain process expertise through training and experimentation then apply process expertise to develop robust manufacturing systems. Identify critical to quality (CTQ) attributes for products and determine key performance input variables (KPIVs) and key performance output variables (KPOVs) related to the CTQs. Complete failure mode and effects analysis (FMEA) to capture CTQs, KPIVs and KPOVs, and establish processes that address CTQ needs. 14. Act to continually improve operations processes through projects, experimentation, designs, and process enhancements. Plan, specify, and implement process improvements, machine modifications and mold improvements. Proactively collaborate with other engineers and operations personnel to ensure that written specifications and designs meet business needs and best practices. Develop, debug, and troubleshoot existing and new manufacturing processes (molding, printing, treatment, assembly, packaging, automation, etc.). Determine and document optimum production process parameters. 15. Use 10 Step DMAIC, Six Sigma, 8D and other problem solving methodologies for hypothesis testing, process capability studies, statistical process control determination, measurement systems analysis, and development of process controls systems. 16. Validate production processes as needed using site validation processes. Establish and implement validation plans and document validation results. Identify processes operating outside of validated state through production audits and take corrective actions to return processes to normal operation. 17. Strictly adhere to requirements of the plant quality systems including compliance to the change control procedure when introducing or modifying manufacturing processes and equipment. Improve the robustness of the plant quality system by creating or revising documentation (quality documents, layout drawings, etc.) in response to identified needs or changes to existing processes. 18. Participate in new product development, capacity expansion, and process improvement projects as a core team member or core team leader. Apply the BD GPDS process to ensure project rigor. Work collaboratively with others to bring projects to completion on time, under budget, and with planned resources. 19. Experience with computer software applications including Microsoft Office, Visio, MS Project, AutoCAD or Solidworks. Preferred experience with Minitab, and SAP.