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.