SUMMARY

• Over 6+ years of experience as a Validation Engineer with expertise in Root Cause Analysis, Process Validation and Packaging Validation, and Continuous Quality improvement.
• Familiarity with statistical analysis methods me.e co - relation, Principle component analysis. etc
• Familiarity with various Root Cause Analysis.
• Proficient in MS Excel and other MS office tools
• Involved in Process Validation and Test Method Validation.
• Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping.
• Subject matter expertise in packaging engineering or device/combination product assembly.
• Knowledge of ISO, ASTM and ISTA Packaging Standards.
• Experience using Statistical Process Control and process analytics
• Ability to assist in test method/setup optimization, test fixture optimization, test data and yield
• Analysis and real-time investigation of yield and test issues for both in house and outsourced assemblies.
• Hands on experience in DFMEA and PFMEA Analysis.
• Validated packaging equipment and packaging manufacturing processes.
• Performed Gap Analysis determining 21 CFR Part 11 applicability and compliance, determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Drove supplier development by assisting them in developing problem solving control tools such as: 8D, process mapping, FMEAs, mistake proofing, SPC, Process Capability, Gage R&R, etc.
• Audited injection molding processes against the Master Process & Control Plans.
• Developed and maintained QAR (Quality Assurance Report) books.
• Assisted in procedure development and maintenance, quality validation after mold repair, including capability studies, Gauge R&R, first article reports, etc.
• Experience in SolidWorks, CATIA, Pro-E ; 2D and 3D modeling experience.
• Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: Minitab, Mat Lab, R - tool and S-tool
• 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, interaction plot, process capability study to optimize the blending and compression process.
• To assimilate and show compliance with the applicable Title 14 CFR regulations per the agreed upon PSCP for each STC project.
• Coordinated with Quality and engineering team to obtain successful completion of FAA and Validation.
• Use of Software and technologies: Auto-CAD, Solidworks, Autodesk Fusion 360, Inventor, Six sigma methodologies, GD &T, FMEA.
• Compile, analyze, and interpret preliminary experimental results using Microsoft Excel and a Minitab Statistical Software
• Designed the components for valve assemblies using Auto-CAD, ASME Y14-X, ASME Y14-X, B16 (valve specifications), GD & T analysis techniques for drafting purpose, and submitted technical reports for review and approval.
• Successfully designed 3D models of different valves (butterfly, globe, ball) for testing and analysis purpose with the use of Pro-E and ANSYS.
• Experience with components of Lean Manufacturing.
• Strong foundation knowledge of statistics, regression analysis, clustering, bootstrapping etc.
• Experience with medical device compliance requirements based on FDA Quality Systems Regulations

TECHNICAL SKILLS

Validation: FMEA, Lean/Six Sigma, Validation plan, Audit Trails, Validation Summary Report, System procedures

Software Applications: Pro-E, Solidworks, Simulink, Auto-CAD, Autodesk Inventor, Autodesk Fusion 360, MATLAB, ANSYS, CATIA V5, Labview, Microsoft Suite, and Adobe Photoshop

Standards: ISO, ASTM and ISTA21 CFR Part 11, Part 210, 211,820

Programming Languages: HTML, CSS, C, C++, NC programming, CNC programming

Additional Software: MS Excel, MS word and MS power point, database creation in MS access

PROFESSIONAL EXPERIENCE

Confidential, Warsaw, IN

Manufacturing Engineer

Responsibilities:

• Lead the development, implementation, maintenance and continuous improvement of manufacturing processes, tools, fixtures and inspection to increase efficiency, flexibility, production, quality and dependability of existing products.
• Maintained and used a variety of continuous improvement tools such as PPM reports, FMEA, and process mapping to identify supplier quality problems and formulated action plans based on analysis of the data.
• Advised on efficient packing processes, procedures, innovations in packaging materials as improvement opportunities.
• Evaluated processes, procedures, data, tools and fixtures to identify causes of specific quality & manufacturing issues that may affect production and quality, tan worked with Engineering and Production to improve processes, tools and fixtures.
• Worked with Engineering to establish and maintain part and assembly specifications.
• Initiated CAPAs and ensured timely completion of CAPAs.
• Performed TMV’s for Visual Inspection dimensional measurements.
• Created test methods and fixtures for destructive strength tests.
• Developed and executed protocols for package design, packaging processes validation and package shelf life testing.
• Reviewed the Design History Files (DHF).
• Hands on experience in DFMEA and PFMEA Analysis.
• Validated packaging equipment and packaging manufacturing processes.
• Performed Gap Analysis determining 21 CFR Part 11 applicability and compliance, determining completeness of qualification and validation testing, and determining the completeness of supporting procedures as required by their standards.
• Assured product and process quality by designing testing methods; tested finished-product and process capabilities; established standards; confirmed manufacturing processes.
• Evaluated and improved production according to those specifications and quality standards
• Documented processes and systems while creating improvements.
• Performed root cause analysis for product/process failures.
• Performed system validation using GAMP guidelines to conform compliance to FDA and 21 CFR Part 11 requirements.
• An integral role in quality, manufacturing, and development of medical device product which includes oversight of manufacturing processes, introduction of new manufacturing processes, component inspections and continuous improvement projects.
• Responsible for product design reviews and mold transfer process.
• Drove supplier development by assisting them in developing problem solving control tools such as: 8D, process mapping, FMEAs, mistake proofing, SPC, Process Capability, Gage R&R, etc.
• Audited injection molding processes against the Master Process & Control Plans.
• Developed and maintained QAR (Quality Assurance Report) books.
• Assisted in procedure development and maintenance, quality validation after mold repair, including capability studies, Gauge R&R, first article reports, etc.
• Developed and maintained SPC database.
• Developed measurement methods and designed simple fixtures to enable accurate measurement of parts.
• Operated various inspection instruments and hand held gauges.
• Ability to oversee the documentation of nonconformities, trending of company processes, as well as documented nonconformance’s into the Corrective Action/Preventative Action (CAPA) program.
• Responsible for conducting and closing investigations, determining root cause, and implementing/closing CAPAs.
• Maintained, reviewed, and updated the company on the latest standards (ASTM/AAMI), guidance, and applicable requirements from regulated bodies (FDA/ISO).
• Authored Test Protocols and performed Test Method Validations for mechanical devices.
• Validated Test Fixtures, Test Assemblies and Gauges

Confidential, Newnan, GA

Validation Engineer

Responsibilities:

• Facilitate Annual Risk Review and Risk Benefit Analysis, update Risk Assessment and Control Table, DHF, and Change Control documentation.
• 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, interaction plot, process capability study to optimize the blending and compression process.
• Compile, analyze, and interpret preliminary experimental results using Microsoft Excel and a Minitab Statistical Software
• Initiate change controls into Trackwise system.
• Monitored, measured and reported manufacturing performance and developed new techniques to reduce losses and improve quality. Recommended and implemented changes to product or process which would improve cost, delivery, and quality for the customer.
• Assured process adheres to the company quality program and planned by performing audits and recommending corrective actions. Confirmed proper documentation is on production floor for the manufacture of customer's product.
• Participated in devising ways to effectively implement the principles of Lean and support a culture of continuous improvement.
• Developed programs and methods to optimize production capability and reduce cycle time, improving manufacturing efficiency, and overall productivity.
• Analyzed process to recommend floor layout and facilities justification.
• Participated in overall product strategy, development, and manufacturing coordination for new and emerging products
• Performed Packaging Validation as per the packaging defects listed in the material specification document
• Perform accelerated aging testing to support shelf life requirements per ASTM F1980 (Accelerated Aging of Sterile Barrier Systems for Medical Devices)
• Worked on the System and Substem requirements for Form/Fill/Seal products packed in perforated arrays, Tyvek Pouches, Cartons.
• Experience in Unique Device identification (UDI).
• Performed Testing, Verification & Validation of the Medical Products and write Protocols & Final reports.
• Label Validation-Evaluate the adhesion of different types of Labels on Container Systems
• Authored Protocols and Conducted Pull Force Test to evaluate the Peel off force of labels
• Communicate with the label vendors for the development of Labeling System
• Developed and improved Packaging related design specifications for components
• Review and Document the DHF Deliverables such as D&D plan, Verification & Validation plan, and Change Control
• Works as part of an Engineering team performing standard engineering work requiring application standard engineering techniques, procedures and criteria.
• Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project. Support development activities for new and modified medical products.
• Create and manage schedules, track action items, coordinate/run meetings, and provide support to other project management activities by communicating with the Manufacturing, Human Factors, Bioscience & Marketing teams.
• Analyze Measurements, Perform Signal Processing, Automating Test and Validation Systems.

Confidential 

Design Engineer

Responsibilities:

• Calculation of required CV’s generated noise for different types of valves.
• Design optimization for different objectives including reliability, efficiency, weight, serviceability and cost.
• Responsible for all engineering aspects of the design.
• Select suitable material based on application -strength, corrosion, hardness, machinability and cost.
• Brainstorm with other engineers, creating sketches of concepts that meet functional requirements, is designed from the outset for manufacture, assembly, and ease of use.
• Develop, maintain and upgrade analytical tools, programs and design methodology.
• Support Marketing, Manufacturing and Service groups.
• Participate in multi-functional teams.
• Provide program status updates to program manager/team.
• To support the production-engineering group was primary motive.
• Designed the components for valve assemblies using Auto-CAD, ASME Y14-X, ASME Y14-X, B16 (valve specifications), GD & T analysis techniques for drafting purpose, and submitted technical reports for review and approval.
• Successfully designed 3D models of different valves (butterfly, globe, and ball) for testing and analysis purpose with the use of Pro-E and ANSYS.
• Designed components with metals, plastics and composites using different manufacturing processes including machining, casting, fabrication and injection molding. Acquired knowledge about designing of pattern (Core, Cavity) for molding, machining drawings of valve parts.