Mechanical Engineer Manager

YASSER ESTAFANOUS

Brandon, FL *****

Email: *********@*****.***

Cellular: 813-***-****

www.linkedin.com/pub/yasser-estafanous

Mechanical Engineer (6σ-TQM-ISO9001)

A Team Leader in Project Management with experience 18 years, complemented by QMS, Design, analytical, Risk analysis, troubleshooting, Installation and communication skills

-Mechanical Engineer experienced in Design, Production and Quality Assurance

-Team Leader in developing and testing products, with 8 years statistically proven experience, TQM, ISO9001-2015/ISO13485, RCA and CAPA, IQ,OP and PQ

-Large experience in installation and commissioning of packaging, Filling, Sealing in Drugs manufacturing using GMP/FDA Regulations (CFR Part 21 Sec.820),

-Risk management plan and analysis

Core Strengths

Preventive Maintenance

Quality Control/Assurance Certified (SPC, DOE, SCM)

ISO 9001:2015 QMS

Diploma in (Lean Manufacturing &Product design-6 σ)

Fundamental Engineering Certified (FE)

OSHA Certified (Safety awareness)

Diploma in TQM

Autodesk (Inventor- AutoCAD)

PROFESSIONAL EXPERIENCE

Invacare (Top End)

Florida Pinellas Park 08/01/2016-Till Now (Limited contract)

Validation Engineer: Applying Quality Management system ISO13485 and 21 CFR 820

According to FDA regulation. Conduct validation & qualification tests of existing processes, equipment, software in accordance with internal protocols or external standards. Develop validation master plans, process flow diagrams, test cases, standard operating procedures. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems&equipment.

Robotic Parking System Inc.

Florida Clearwater. from 05/01/2016-07/30/2017

Mechanical Design Engineer/QMS Management Representative:

Responsible for overseeing manufacturing of machinery, testing, shipping; assisting with design and shop drawings, supervision / coordination on assigned projects if needed.

Overseeing the manufacturing process of the Robotic Parking Systems’ machinery.

Ensure all components are ordered and are available as required according to production timelines.

Detailed testing and quality control of machinery on the shop floor.

Oversee packaging and loading of machinery and equipment for safe shipment to the job site.

Detailed shop drawings for steel and generating general assembly drawings for the steel structure for automated car parking garages in AutoCAD 2D.

Develop plans for erection and commissioning

Modification as needed of existing machine designs and detailed shop drawings in Inventor 3D. Detailed machine design and detailed shop drawings for any new automated robots in Inventor 3D (Motor,Gearbox,Actuators,Bearings).

Co-ordinate with the steel erection team for implementation / installation of machines if needed.

Co-ordinate and in charge of MEP, electrical and steel installation for the project if needed.

Project management including liaison with Consultant and Client for technical and commercial approvals if needed.

Act as management representative and implement the ISO 9001:2015 system for the organization. Compiling existing materials and coordinating with areas to create any new materials needed for certification.

Applying Root cause analysis and FMEA for continuous improving process.

After designing robots, responsible for prototype and testing in the factory.

Developing and executing Factory Acceptance Test.

Control change document process to implement only approved and validated changes.

Make client presentations about the product if needed.

Carry out QMS Audit semi-annually.

IMR Environmental equipment

Florida Saint Pete. from 04/01/2013-04/30/2016

Supplier Quality Manager:

Provided engineering support to operations ensuring consistent application of quality techniques

Resolved quality issues of capability, tolerance, and materials related issues.

Resolved quality issues by identifying problems, examining solution options, implementing action plans, and providing resources.

Continuously ensured both new and existing customer requirements were maintained throughout the manufacturing process; assisted in implementing 5S principles within specific product lines to improve footprint of product and reduce waste while ensuring products adhered to all customer requirements.

Performed internal audit functions for an existing ISO 9001:2008/2015 certification. Aided in developing and facilitating Internal Auditor Training for both new and existing employees.

Experience with using and creating SPC (Statistical Process Control), fish bone analysis, cost-effectiveness analysis, PPAP and Control Plans.

Consolidated test data to support PPAP development specifications; investigations of product inconsistencies, and qualification of changes in manufacturing process. PFMEA and Control Plans.

Performed Supplier/Vendor Certification Audits to ensure compliance to required regulations.

Assisted in analyzing, designing, developing, implementing, and evaluating new processes and equipment for new products.

Smart Way for pharma Equipments, Cairo, Egypt

01/2005 - 02/ 2013

SmartWay is a Leading company in the field of Industrial Filling, Sealing and Packaging (machines & Materials) For Drugs, Beverage and Food Manufacturing Companies

Technical Quality Manager: Leading Depart. of Installing, Commissioning and Maintenance of filling, Sealing and Packaging in Pharmaceutical, Beverage and Food Companies which need special requirements like Aseptic processing and Environmental Control&GMP/FDA Working With(J&J-GSK-Pfizer-Astra Zenca)

Get sure that all Stages of production subjected to sterilization methods like glass or rubber

Developing Process Equipment User Requirements(URS)/IQ/OQ/PQ.

Developing and executing Factory Acceptance Test.

Implementing (site Acceptance, Validation and Personnel training).

Control change document process to implement only approved and validated changes.

Process technology development For Continuous improvement.

Lead or assist in the risk analysis process. Execute risk assessment as needed and facilitate development and completion of risk management file documentation.

Experience in using all problem-solving techniques like (8D – 5 Why) and SPC for effective root analysis.

Applying and creating risk management plan and Analysis(SWOT) to reduce cost and waste.

Al Augizy International, Cairo, Egypt : is a Leading company in th e field of Packing,Packaging,inkjet machines and Metal detector machines,agent of( Robopac Italy, Goring Kerr England, Domino England)

Technical Support Supervisor : 01/2000 – 12/2004

Supervised five (5) engineers and eight (8) technicians.

Verified engineering program documentation standards and test procedures

Managed 12 new projects, valued at $6.5M

Managed the Technical filing system to maintain status of the customer database.

Managed expansion of service contracts valued at $1.5M annually.

Managed customer accounts by review of service contracts, renewal dates, and

review comments.

Supervised Technical Support Team, improved services by 20 percent.

Field Engineer 1/1995 – 12/1999

Mechanically installed, repaired and commissioned over 585 machines for:

oPacking, Packaging machines (150 Robopac)

oMetal detector machines (85 Goring Ker)

oIndustrial Inkjet machines (350 Domino)

Achieved the sale of 100 machines, valued at $3M

Established a monthly schedule for a maintenance program for each customer.

Recommended the spare parts required for regular maintenance to all customers.

EDUCATION

Bachelor of Science (BS) - Mechanical Engineering

Cairo University, Cairo, Egypt

CERTIFICATIONS

-OSHA safety awareness certificate

-Fundamental Engineering Certification (FE) New York Board of Engineering

-BSME credential evaluation and Authentication, Sept.,2012 (World Education Services NY)

-PMP Certification

-Six Sigma Diploma, Risk management Diploma – Manufacturing& Product Design Diploma

-TQM Diploma

TECHNICAL PROFICIENCIES

-AutoCAD 2D & 3D, 2013 Certified – Autodesk Inventor 2015)

-HAP 4.6 Cooling load design &Calculations

-Microsoft Office 2016 (Word, Excel, Project-Outlook) – Adobe- Power point

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