R D Validation Engineer

Ahmed Eldawansy

Lake Forest, CA *****

Summary of Qualification:

• Ahmed holds a Master’s degree with experience as an R&D Engineer, Validation Engineer, Process Validation Engineer, and Mechanical Engineer in the Medical Device and Manufacturing industries.

• Design Verification Testing (DVT) for critical care products: Catheters, microcatheters, and Balloons to improve the clinical procedures for medical devices.

• Experience in Medical Devices R&D, component re-design, process development, optimization, Quality, and manufacturing.

• The validation process from start to finish includes writing protocols/master plans/test methods/sample size.

• Writing IQ/OQ/PQ/PPQ protocols and reports for equipment and process test method validations.

• Experience with CAD, SolidWorks, Agile PLM, MATLAB, and Minitab

• Transfer engineer for new products from R&D to manufacturing including plan for Qualification and Verification process and getting approvals.

• Set up all levels of supplier selection, and activities and ensure quality parts at the receiving stage.

• Performing FMEA on all levels of pre- and post-production.

• Working closely with R&D and Process Engineers to transfer design to production.

• Creating and updating process flowcharts, PFMEA, BOM, and manufacturing work instructions.

• Performing CAPA investigations.

• Defining and planning budgets, schedules, and resources for manufacturing operations.

• Knowledge in ISO-11070, ISO-9001, ISO-13485, and FDA 510k guidelines. Location:

• Lake Forest, CA 92630

Current job search activity:

• He has a few interviews in hand.

• No Offers and no planned vacations.

Edwards Lifesciences Applications:

• He has not worked for Edwards previously (contractor or FTE). ·No

• He has not applied or interviewed for an Edwards FTE position within the last 30 days.

• No pre-planned time off - No

SKILLS:

• SolidWorks

• CAD

• Agile PLM

• MATLAB

• Minitab

• MS Office Suite (Excel, Word, Outlook and PowerPoint) EDUCATION:

• M. SC. in Mechanical Engineering, Gannon University – Erie, PA

• B. SC. In Mechanical Engineering, Arab Academy for Science and Technology – Alexandria, Egypt PROFESSIONAL EXPERIENCE:

BD Medical – Medication Delivery Solutions Brea, California Jan 2023 – Dec 2023 Quality Engineer

• Working on R&D for IPD (Infusion Preparation & Delivery) Medical Devices (Needle connector, Catheters Ext Sets, and Admin Ext Sets).

• Providing Design Verification Testing (DVT) protocols and reports to improve the clinical procedures for the device.

• Writing IQ/OQ/PQ/PPQ protocols and reports for equipment and process test method validations.

• The validation process from start to finish includes writing protocols/master plans/test methods/sample size.

• Support R&D and product & process development team from concept phase up to commercialization, such as design outputs definition, development and implementation of design controls, process development, v & v testing, and design transfer to manufacturing.

MEDTRONIC, NEUROVA SCULARUCI, Irvine, California Feb 2022 – Nov 2022 R&D & Validation Engineer

• Working on R&D for Neurovascular Medical Devices (Microcatheter, guide wires, and balloons).

• Providing Design Verification Testing (DVT) protocols and reports to improve the clinical procedures for the device.

• CAPA investigation on material change.

• The validation process from start to finish includes writing protocols/master plans/test methods/sample size.

• Writing IQ/OQ/PQ/PPQ protocols and reports for equipment and process test method validations.

• Writing design change impact assessment reports as per the Neurovascular remediation plan. NESTLÉ Pittsburgh, PA Jun 2021 – Sep 2021

Process Validation Engineer

• Researching to develop new improved processes for manufacturing.

• Conducting tests and monitoring the process performance through production.

• Establishing safety procedures for individuals working with dangerous chemicals.

• Validation process from start to finish including writing protocols/master plans/test methods/sample size

• Monitoring production processes, researching opportunities for improvement, and proposing solutions.

• Working with production leaders on operational/mechanical issues and facilitating resolution of repetitive issues. SUPER-PUFFT SNACKS CORP. Perry, FL Jun 2020 – May 2021 Mechanical Engineer

• Worked as a full-time Mechanical and Operations Engineer at Super-Pufft Snacks Corp.

• Trained in Ishida Multihead Weighers and Packaging machines.

• Install, maintain, modify, and troubleshoot industrial automated systems.

• Install, calibrate, and troubleshoot sensors, actuators, valves, controllers, and displays in applications for product handling and packaging.

• Design, implement, and install safety features and alarm systems to the winding machine.

Contact this candidate