More than 13 years of experience in manufacturing engineering, with a strong emphasis in machine and process validation. Experienced in handling product transfers, equipment /process automation and software validation projects. Skilled in developing and implementing standardized policies and procedures. Results oriented and able to adapt and learn in a changing environment.
PROFESSIONAL EXPERIENCE
Charter Medical •Winston-Salem, NC November 2012 – Present
Senior Manufacturing Engineer
Key Projects and Accomplishments:
• Lead and participate in the design and development of manufacturing processes for new products
• Support prototype and pilot production of new products
• Provide engineering and technical support to operations team
• Coach and mentor junior engineers in the practice of project management including planning, execution, and meeting time and budget constraints
• Responsible for generating, executing and reporting process specification, validation qualification protocols.
• Utilize Lean Six Sigma (LSS) tools and concepts to assist in process improvements, both within the company and externally at our customers/suppliers.
• Lead root cause analysis process for internal and supplier non conformances.
• Manage site master validation plan project.
Covidien • North Haven, CT March 2008 – November 2012
Senior Manufacturing Engineer
Provided expert daily direction in set-up, trouble shooting, repair and continuous improvement of automated packaging production equipment. Ensured safety aspects of the equipment met specifications and requirements to assure employees safe working conditions. Served as the resident expert on production equipment and processes and provided education to engineers, manufacturing and maintenance personnel to ensure efficient product processing.
Key Projects and Accomplishments:
• Safety system upgrade for three Form/Fill/Seal packaging lines.
• OEE improvement for Multivac Packaging machines resulting in a 25% increase in productivity.
• Worked with vendor to redesign packaging tooling which resulted in 33% increased uptime.
• Vacuum drying systems validation project to reduce product handling which led to savings of $100K.
• Barcode inspection system implementation to reduce labeling defects.
• Working knowledge of statistical tools such as DOE, SPC, Hypothesis Testing and Process Capability Studies.
• Experienced in the use and troubleshooting of PLC code and software, including Allen Bradley PLC5, SLC500, Micrologix, ControlLogix and PanelView, Mitsubishi, Koyo, IDEC and Automation Direct.
• Experienced supporting medical devices packaging machines (Multivac, Tiromat, Klockner, Mahaffy), robotic applications (Adept, Yamaha SCARA robots) and automatic vision systems (Cognex, DVT, Adept).
Covidien • San Isidro, Dominican Republic March 2004¬¬ – March 2008
Project Engineer
Managed multiple projects, machinery validation and software validation. Served as the project leader for the installation and validation of Vision Inspection Systems on foil packaging lines. Trained plant employees under the Lean 101 training program on fundamentals. Worked as the key member of Kaizen teams to improve processes. Utilized SMED concepts to reduce the change over time in packaging lines.
Key Projects and Accomplishments:
• Project leader for the SAP to BPCS implementation project. Managed a team of 10 engineers for nine months to convert from one system to the other.
• Achieved 200K in savings by fabricating spare parts in house. Managed CNC machine acquisition and implementation of CAD/CAM software.
• Project leader for the implementation of the software-based Work Order, Preventive Maintenance and Calibrati...
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