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Click here or scroll down to respond to this candidate Candidate's Name
Coral Springs, FL Street Address
PHONE NUMBER AVAILABLE (Cell)E-mail: EMAIL AVAILABLE Senior Manufacturing EngineerPROFESSIONAL SUMMARY:
Dedicated Engineer in Medical Device Industry with experience in optimizing and managing complex industrial processes. Proficient in continuous improvement by implementing lean manufacturing principals and methodologies to reduce waste and optimize processes. Monitor operation to improve safety, quality, efficiency and cost by identifying process concerns and implement improvements.ACCOMPLISHMENTS: Conducted Distribution continuous improvement project resulting in conveyor reduction of 40% and productivity improvement of 30%. Successfully completed barrel wrapping relocation resulting in footprint reduction of 75%. Designed and implemented part presentation work stations for several reagent fill, cap, label and packaging lines resulting in productivity improvements of 20 - 50%, OTD of 10 - 30%, and footprint reduction of 40 -75%. Implemented standard work that reallocated operators to operate multiple operation simultaneously.
Increased yield of Hemoccult ICT from 60% to 95% by process optimization.
Successfully generated and executed scale up validation protocols for reagent volumes 30L to 120L and 90L to 360L to address increase production demands.
Supported validation activities for the introduction of Capio RP Suturing Device and Injection Gold Probe/Gold Probe bipolar cable adapter.SKILLS:Value Stream MappingLean Manufacturing5 Why MethodologyProblem SolvingProcess MappingCause and Effect Diagrams6S implementationVisual ManagementSpaghetti DiagramFacilitate Kaizen eventsValidation Project PlanInstallation Operational QualificationsDMAICProcess ValidationValidation Final ReportFactory Acceptance TestSite Acceptance TestPerformance QualificationStandard Operating Procedure(SOP)Lean Six Sigma Green Belt CertificateToyota Production SystemQuality Management System(QMS)FDA/cGMPISO 13485PROFESSIONAL EXPERIENCE:
SHL Pharma Deerfield Beach, FL Aug.2021 March 2024Senior Process Engineer
Execution and commissioning of process qualification of Auto injectors for final assembly production lines, labelling & packaging engineering floor support, and the serialization. Collaborated with multi-functional teams in pre-commercial and commercial activities. Coordinated with cross-functional internal resources and third parties/supplies for timely execution of the project. Drafted new equipment design documentation (e.g. User Requirements, Functional Specification, Hardware, software Design Specification, etc.)Clinical Diagnostic Solution Plantation, FL May 2019 Aug.2021Senior Process EngineerGenerated validation project plans for process improvements for scale up production for reagent manufacturing. Design and implemented new fixtures for filling process to supported scale up process. Validated new labeling equipment and implemented labeling line.
Danaher - Beckman Coulter Hialeah, FL Sept.2016 May 2019Supervisor Reagent ManufacturingManaged team of 10 associates and constantly meeting monthly production volumes. Maintained and documented work completed on a daily basis; presented the report to the management. Coordinated with human resources department in hiring the appropriate individuals for the workforce and assisted in designing appropriate training programs. Conducted briefings and meetings before and after work sessions, which included praising individuals as well as clarifying various areas that they need to be improved.Danaher - Beckman Coulter Hialeah, FL June 2011 Sept. 2016Senior Analyst Continuous Improvement
Trained associates on lean tool to eliminate non value added activity resulting for a more efficient process. Organized and facilitated Standard Work Kaizen resulting in productivity opportunities and eliminated non value activities. Organized and facilitated Kaizen resulting in inventory and lead time reduction. Organized and facilitated problem solving process using VSM to eliminate waste, 5 why methodology, Cause and Effect diagrams to determine root cause and implemented countermeasures. Identified, analyzed, and enhanced existing processes, as well as developed new processes for products transfers. Designed and fabricated Part Presentation Vehicle and generated and implemented Kanban pull systems.Beckman Coulter, Inc. Hialeah, FL Oct.2006 June 2011Senior Technical Operations Engineer
Implemented Lean Manufacturing principles using Value Stream Mapping. Developed and implemented productivity for manufacturing processes and cell design. Identified, analyzing, and enhance existing processes, as well as develop new processes for new products that are within existing capabilities in Instrument and or Reagent manufacturing. Interfaced with supplier quality, incoming inspection and many manufacturing functions to implement lean practices. Evaluated associates task and responsibilities, identification procedures or tools to improve productivity. Experiences in creating manufacturing documents in compliances with ISO and GMP.Nipro Diabetes System Miramar, FL Jan.2006 Oct.2006Product Development Engineer/Technician
Oversaw, reviewed and evaluated new production processes and implement process improvements. Created manufacturing and maintenance procedures. Created documentation including quality procedures, manufacturing procedures, process validation protocols and reports and maintenance documentations. Designed and implement new equipment and fixtures. Drive technology development by performing and documenting experiments for new product/processes and performing validations/qualifications.Boston Scientific Corporation Miami, FL July 2000 Jan. 2006Manufacturing EngineerReviewed and evaluated production processes and implemented process improvements. Monitored manufacturing and maintenance procedures and revise documentation. Reviewed daily production output and solve production problems. Performed failure analysis on reject product. Created and updated documentation including CAD and electronic imaging for: drawings, quality procedures, bill of material, manufacturing procedures and routings, process validation protocols and reports, maintenance documentation. Created project/capital equipment justification. Designed and implement new/modify equipment and fixtures. Investigate and procure manufacturing equipment for process improvements. Provided leadership to technician support personnel and monitor and assist them as needed.
EDUCATION:
Bachelor of Science, Industrial & Systems Engineering
Florida International University, Miami, FL
Bachelor of Science Mechanical Engineering
University of Florida, Gainesville, FL
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