Project Engineer Mechanical Engineer Contractor resume example with 20+ years of experience
- PMI-PMBOK, Critical Chain Project Management, Waterfall, Dependency Structure Matrix
- Technical and Business Leadership
- New Product Development
- Design Change Project Implementation
- Facilitation, planning and organization skills
- Resource, Scope, Schedule, Budget, and Risk Management
- Design Control (FDA's 21 CFR 820.30)
- Mechanical, Electro-mechanical, Plastic/Mold, CAD/CAE/FEA, Software and Systems Engrg
- Cross-Functional Team Leadership
- Regulatory Affairs (RA), Post Market, 510K
- Quality Systems, Corrective and Preventive Action
Natural Science, Chemistry
University of La Verne, MBA Finance
University of Irvine, Regulatory Certification
ā¢Oversaw and directed up to 160 projects ranging from small to large sizes with varying complexities over a span of 7 years. Met approximately 70%-100% assigned completion dates.
ā¢Completed two projects in the Therapeutic Drug Monitoring (TDM) group, six months prior to the scheduled due date, resulting in manufacturing cost savings and customer satisfaction.
ā¢Integrated several complex procedures into one process flow and improved efficiencies by 30%.
ā¢Principal of an engineering service company for 12 years, growing the company from zero to $10M.
ā¢U.S. Patents: Self: Sprinkler Cap; Company: Micro-Spray, Clutch Assembly, and Medical I.V.
Englewood, CO, 01/2010 - Current
- Managed multiple engineering Design Change and New Product development projects for high level disinfectant capital equipment systems. Orchestrated the execution of product development phase tasks within Design Control process, including User Requirements, Risk Reviews, Design Input, Product/System/Component Specifications, Critical to Quality (CTQ), Design, Development Plans, Cost Analysis, Design Outputs, 3D design and Drawings, Prototyping, First Article Inspection, Testing, Protocols, Reports, Design Verification and Validation, Design Reviews, DHF/DMR Files, Manufacturing Feasibility, Bill of Materials, Traceability, and Design Transfer.
- Collaborated with Quality Assurance, External and Internal Manufacturing, Regulatory, Materials, Electronics, Software Developers, Reliability, Global Technical Services, Supply Chain, Labeling, CAPA Review Board (CRB), Industrial Design, Tooling, Vendors, Finance, Document Control.
- Combined project management tools with new product development/design change process and resolved gaps and disconnects from both to achieve project results.
- Developed robust project schedules and monitored workflow to achieve project deliverables and milestones. Brought transparency to project priorities. Negotiated and directed resources to meet project capacity and milestones.
- Consistently communicated project status to stakeholders. Aligned business objectives with projects and supported management in all aspects of R&D and manufacturing to prepare for a global launch.
City, STATE, 08/2012 - 05/2013
- Provided project management expertise in the R&D Chemistry Development group. Managed CAPA projects, Design Changes and New Product Development to TDM Assays in all phases. Reported to the Vice-President, R&D Manager and communicated project status to project stakeholders.
- Developed project plans with core leaders and managers. Built project framework such as Work Breakdown Structure (WBS) and Dependency Structure Matrix (DSM), ensuring completion of the project timeline. Applied methodology, Critical Chain Project Management (CCPM) using Prochain software to create fever charts and predict project health.
- Created project schedules according to toll gate requirements and optimized dependencies to prevent task delays. Closely reviewed and monitored scope creep.
- Collaborated with PhDs, Scientists, and Clinical Lab Technicians in their efforts toward reagent characterization, formulation, calibration and manufacturing activities to meet project goals.
- Managed Design Control to ensure compliance. Worked with Manufacturing, Quality Control, CRB, Regulatory for approval at each phase of the Reagent/Antibody design changes.
- Held regular project reviews with the project teams. Reviewed task due dates and current issues with manufacturing at Gemba meetings. Prepared project reports, analyses and presentations to Leadership Committee at gate reviews.
- Lead process improvement initiatives, achieving deliverable timelines. Developed and combined procedures to improve project efficiency.
City, STATE, 01/1999 - 01/2004
- Designed mechanical engineering components for the Satellite Space System and subsystem for payload integration group.
- Performed structural, volume, tolerance and analysis.
- Supported telescope/optics electro-mechanical cabling design, heat transfer, materials and stress analysis groups.
- Worked both in Test and Flight mode development phases of the project.
- Supervised contract engineers regarding project workload and task completion dates.
City, STATE, 1980 - 1992
- Led and directed structural analysis and plastic mold flow projects.
- Supervised Mechanical Engineers/Stress Analysts.
- Worked with cross functional teams.
- Performed plastic part design and Plastic Injection Simulation through Finite Element Analysis (FEA).
- Performed tolerance analysis; plastic material selection, water power driven mechanical systems, design and reverse engineering of complex mechanism design for irrigation products such as sprinkler rotors, solenoid valves, impact sprinklers, electro-mechanical controllers, and spray heads.
Project Management Institute (PMI), Society of Mechanical Engineers, Society of Plastic Engineering
MS Project, MSOffice, Excel, Word, PowerPoint, Access, Outlook, Visio, Office 365, SolidWorks, I-DEAS, ProChain, CCPM, DSM, Cognition Cockpit, Share point, Matrix One, Team Center, Project Management, CAPA, QMS, GDP, Design Control (21 CFR 820.30), Risk, Reagent and Calibration Product Life Cycle (PLM), New Product Development, Change Control, Taguchi, Continuous Improvement, DFMA, GD&T, Managing in a Technical Environment.
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Resume Overview
School Attended
- California State Polytechnic University
- Citrus College
Job Titles Held:
- Project Engineer/Mechanical Engineer, Contractor
- Project Manager
- Program Manager/Project Manager/Mechanical Engineer
- Group Leader/Project Engineer
Degrees
- B.S. Degree
- A.S. Degree
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