Project Leader Product Engineering Team resume example with 12+ years of experience
Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
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Professional Summary
Over twelve years of professional experience and knowledge development within the medical devices industry as project leader, project/manufacturing engineer and engineering technician supervisor. Exposed to FDA regulated working environment. With knowledge in the planning, layout, development, optimization and monitoring of manufacturing processes. Also in the design creation, modification, evaluation and development of tools and fixtures. Greatly enjoy sharing knowledge, empowering others, and providing coaching and guidance to enable my team to thrive while meeting business objectives.
Skills
Excellent interpersonal skills
Great Leadership abilities
Excellent planning and coordination skills.
Effective oral presentations
Able to readily adapt to changes in priorities and project schedules.
Enthusiast Team player.
Takes ownership on assigned tasks and outcome.
Experience with regulated environments: cGMPās (CFR 21 Part 210 & 211), GxP, ISO regulations and EPA.
Experience in problem solving, FMECA, OEE, qualifying new utilities and manufacturing equipments.
Working experience in FDA and other regulatory agencies audits.
Education
University Of PhoenixGuaynabo, PR, Expected in 07/2011 ā āMBA:Business Administration And Management - GPA:
University Of Puerto Rico - MayaguezMayaguez, PRExpected in 12/2008 ā āBachelor of Science:Mechanical Engineering - GPA:
Certifications
CAPA Expert Training
Lean Six Sigma Green Belt Certification - Bard Puerto Rico
Yellow Belt Certification - Bard Puerto Rico
PMP - PMI Project Management Certification Course
Work History
Department Of Defense - Project Leader - Product Engineering Team La Palma, CA, 04/2013 - Current
Site leader for EU MDR (European Union Medical Device Regulation) compliance related implementations.
Develop, lead and execute product and technology transfer projects including process transfers (site-to-site) and design transfer (design-to-site) following corporate and site guidelines.
Develop and implement product and process improvements (CI Projects as well as product modification/improvements in order to reduce the potential of having customer complaints).
Develop and execute master validation plans, capital budget request, qualification protocols (IQ/OQ/PQ/TM), line capacity analysis as well as new and existing areas re-layouts.
Ensure all related documentation is in compliance with the Companyās Quality Policies.
Traveled to supplier facilities to perform on-site FATās to new equipments/machines.
Coordinate meetings with operations management team to discuss project scope, align team efforts, understand expectations, discuss timeframe, establish their requirements, address/clarify any concerns and to coordinate the execution of activities required in order to complete project tasks.
Revised, proposed and submitted changes (CRās) for existing and new manufacturing procedures, designs, inspection criteria clarification, tools and BOMās.
Develop and implement new manufacturing travelers for Lot History Record documentation.
Professional mentor for engineering students (COOPās), responsible of assigning tasks, coach them in their execution to assure satisfactory completion and shared experiences.
Supervise and assign project tasks to engineering contractors to ensure engagement/integration and productivity for the overall project execution.
Provide trainings on Qualification procedures to new hires as part of the onboarding process.
Universidad De Puerto Rico - Professor City, STATE, 02/2018 - 12/2019
Used variety of learning modalities and support materials to facilitate learning process and accentuate presentations, including visual and social learning modalities.
Offered career assistance to students by conducting mock interviews, providing relevant job opportunities and teaching networking skills and strategies.
Conducted engaging in-class discussions to facilitate learning and encourage participation.
Pall Life Sciences - BioPharm - Intermediate Manufacturing Engineer City, STATE, 10/2012 - 04/2013
Provided support to manufacturing operations to assure continuous efficiency, ensuring overall process performance to design capability.
Provided effective engineering services to production and manufacturing equipment.
Also, assisted in the design and implementation plans for cost and scrap reduction, quality improvement, process support and verification.
Ensured the production commitments and efficiency by providing problem analysis, testing and implementing corrective and preventive action plans (CAPA).
Completed preventive maintenance routines, documentation and procedures.
ST Jude Medical, LLC - Manufacturing/Project Engineer & Technician Superv City, STATE, 04/2009 - 10/2012
Project leader for first site to implement material change in order to achieve $3M cost reduction across SJM IES Division.
Directly supervised manufacturing and engineering technicians.
Coordinated equipment repair to ensure least amount of downtime of production lines.
Developed manufacturing investigations reports, Customer Complaints Investigations, CAPA & Root Cause Analysis, Project Plan, and Validation/Qualification Protocols and Reports (IQ/OQ/PQ).
Support to manufacturing areas, including subassembly, assembly, welding, leak testing and epoxy casting area, to assure process flow, continuity and compliance with procedures and quality system requirements.
Modified casting process to decrease a non-conformance present in over 80% of production to less than 0.5%
Implemented process improvement projects and obtained over $75K annual benefit by reducing manufacturing rejects and reworks. FPY reflected over 20% increase.
Investigated audit non-conformance as well as customer complaints by providing root cause analysis to explain field and internal failures causes and implemented process improvements and corrective actions to prevent recurrences.
Evaluated and updated FMEAās in order to align it with current processes and add new failure modes analysis.
Revised, proposed and submitted changes (ECOās) for existing manufacturing procedures, designs, inspection criteria clarification and new rework processes.
Develop, planned and implemented new process layout design of subassembly, assembly, welding, and epoxy casting area for capacity increase product ramp up (UPL from 45 units/day to 200 units/day) in order to ensure most productive arrangement of machines and workstations.
Develop, design and incorporated over 20 tools and fixtures for cut open rework process at machine shop with their respective CNC code and procedure.
Traveled to Penang, Malaysia in order to validate multiple reworks using CNC Milling machine, including fixture and code development.
Affiliations
Delta Mu Delta International Honor Society in Business Administration - Delta Mu Delta is a business honor society that recognizes and encourages academic excellence of students at qualifying colleges and universities to create a DMD community that fosters the well-being of its individual members and the business community through life-time membership.
The National Society of Leadership and Success - The NSLS is the nation's largest leadership honor society. Students are selected by their college for membership based on either academic standing or leadership potential. Candidacy is a nationally recognized achievement of honorable distinction. With 700+ chapters, the NSLS has more than one million members nationwide.
In addition to honorable distinction, the NSLS provides a step-by-step program for members to build their leadership skills through participation at their campus or online. Upon completion of the program, members receive their leadership certificate and take their place among the top student leaders at their campus and across the country.
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