OBJECTIVE:

Seeking a full time position to use my skills as a Manufacturing Engineer and be a vital asset to the company.

SUMMARY:

• Working as a Manufacturing Engineer in Confidential to prepare Manufacturing Transfer File (MTF), Process Failure Mode and Effects Analysis (PFMEA), Feature Inspection Plans (FIP) and review Device Master Records (DMR) to perform GAP analysis per Design History File (DHF) remediation.
• Worked as a Validation Engineer in Confidential for disposable medical devices to perform Test Method Validation (TMV) which includes preparing Standard Operating Procedure (SOP), protocols, final reports and conducting Gage R&R studies.
• Worked as an Aerostructures Manufacturing Engineer in Confidential for Bell AH - 1Z Viper program to supervise engineering changes such as tooling, 3D modeling, planning, cost estimating, and preparing First Article Inspection (FAI) AS9102 to build correct parts.
• Strong knowledge about FDA regulations, 21 CFR PART 820, Corrective Action and Preventive Action (CAPA) investigation and Lean Manufacturing concepts.
• More than two years of hands on experience in SolidWorks, CATIA and GD&T.
• Strong problem-solving, time management, team work, communication, interpersonal, and report writing skills.

SKILLS:

Engineering: SolidWorks, UG NX 7.5/ 8.0, CATIA V5, MATLAB, LabVIEW, Minitab, Java, and JD Edwards.

Laboratory: Instron, Low speed wind tunnel, High speed wind tunnel and water tunnel.

Microsoft Office: Word, Excel, Outlook, PowerPoint, OneNote, and Visio.

PROFESSIONAL EXPERIENCE:

Manufacturing Engineer

Confidential, Warsaw, Indiana

Responsibilities:

• Performing GAP analysis as a part of DHF remediation by creating PFMEA, FIP, Measurement Inspection Sheet (MIS) and reviewing DMR for various trauma implants such as plates, screws, and nails.
• Implementing Lean manufacturing principles to reduce defects in chemical etching process.
• Assisting in cleaning validation of Ramco machine by providing surface area and router information.
• Preparing checklist memo and closure memo for Manufacturing Transfer File (MTF) to ensure whether there are gaps or not by checking product prints, bubble drawings, gauge prints, Bill of Materials (BOM), processing routers, CNC setup sheets, etch setup sheet, product labels, packaging set-up sheet, FIP, and MIS.
• Initiating Manufacturing Change (MC) request in Change Management System (CMS) to update routers.
• Experience using UG NX 8.0 to view models and JD Edwards to inquire routers, BOM, cost, and inventory.

Validation Engineer

Confidential, Round Lake, Illinois

Responsibilities:

• Worked as a Project Lead for disposable medical devices (nutrition products) by managing team of three engineers and utilizing team effort efficiently to complete the project ahead of time with high quality work.
• Prepared and reviewed SOP, protocols, final reports, and Master Validation Plan (MVP) for quality assurance/ product support.
• Extensive experience in Test Method Validation (Gage R&R, inspection method, attribute test method, compendium method, destructive test method, non-destructive test method, and variable test method) for disposable medical devices.
• Performed Design of Experiments (DoE) using Minitab 16 and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R, Gage linearity and Bias study.
• Created Master Validation Plan flow chart to synthesize activities and shorten project completion time.
• Knowledgeable in FDA regulations, ISO standards, and ASTM standards.

Aerostructures Manufacturing Engineer

Confidential, Jacksonville, Florida

Responsibilities:

• Successfully supervised more than 400 engineering changes associated with tooling, modeling, planning, and cost estimating for Bell AH-1Z Viper program.
• Excellent hands on experience and knowledge of FAI, GD&T, and CAPA.
• Gained extensive experience in NX 7.5 to view and compare 3D models.
• Prepared Parts Status Request (PSR) for engineering changes by analyzing Computer Aided Process Planning (CAPP) routes, Shop Sketches, 3D models, Bill of Materials (BOM), Conventional Inspection Sheet (CIS), and FAI AS9102 to decide whether to update models, stop work or rework to build correct parts.
• Delivered Factory Change Estimates (FCE) to customer by providing cost impacts due to engineering changes such as purchasing impact, tooling cost, and evaluated required hours to accomplish requested changes.

Confidential

Team Leader

Responsibilities:

• Coordinated a team of seven members and worked efficiently as Confidential team leader.
• Designed, tested, and analyzed the modification in structures of a remote control airplane.
• Used SolidWorks to design wing and tail structure of a remote control airplane for greater stability at low speed.
• Flow Visualization Analysis, Low speed Laboratory Aug 2010 - Dec 2010
• Researched on delay of flow separation over a cargo truck model by using vortex generator.
• Used MATLAB to analyze drag effect by three dimensional representations of flow patterns.
• Experienced inclusiveness and cultural diversity by working with diverse team members.
• Design Project Team Leader, Engineering Graphics Design Aug 2009 - Dec 2009
• Served as a design project team leader for a team of five engineering students.
• Used SolidWorks for solid modeling, and assembling various parts.
• Completed design work in a timely manner and created prototype.
• Member of Design Build Fly (DBF) Jan 2009 - May 2009
• Designed and built lightweight aircraft for annual DBF competition.
• Used composite material (i.e. carbon fiber) for the design of fuselage to reduce weight of the aircraft.