AMER EL-HAGE
2101 Manzanita Ave.
Menlo Park, CA 94025
415-314-9267
amer@beestonengineering.com
SKILLS /SPECIAL QUALIFICATIONS:
Product development of scientific instruments; technical consulting in mechanical design, fluid handling,
plastic injection molding, micro-devices, test and qualification and transfer to manufacturing. Has excellent
applicable knowledge of FDA, ISO, UL and CE regulations for instrument development.
TECHNICAL EXPERTISE:
Program Management, Product Development, Quality Engineering, Computer Aided Drafting (Pro/E,
SolidWorks), Design Controls, Metrology/Calibration, Process Optimization, Risk Analysis, Failure Mode
Effect and Criticality Analysis (FMECA), Failure Analysis (FA), Root Cause Analysis, Environmental and
Reliability Studies, Statistical Process Control (SPC), Development Lifecycle/ Quality Programs,
GMP/ISO 9000/ISO13485/CE/ FDA Quality System Regulation (QSR), Medical Device Directive (MDD)
WORK EXPERIENCE:
2004 -Present
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2000-2004
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1991- 2000
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1987- 1991
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Beeston Engineering Consulting, Menlo Park, CA
Principal Consultant
Assignments for medical device, bio-analytical, and life science fields to develop instruments, product
designs, and the manufacturing quality strategies for release to manufacturing by:
Assisting with development and implementation of product design systems and validation programs.
Developing procedures related to instrument design, verification and transfer to manufacturing.
Conducting assessments of programs to determine compliance with ISO, CE and FDA regulations.
Molecular Devices Corp, Sunnyvale, CA
Director, Engineering
Responsible for the transfer of technology and release to manufacturing of MDC first automated
High Throughput Electrophysiology product.
Developed and lead the product release project for a High Efficiency image detector system.
Coordinated concepts and design reviews, verification, reliability and life testing of new products
Developed and released an updated MDC Product Development Process for ISO Design Control.
LJL BioSystems, Sunnyvale, CA
Senior Director, Engineering Programs
Responsible for contract product project development which includes conceptualization,
specifications, budget, schedule and resource allocation
Identified and hired technical resources needed to build the R&D department
Developed the verification and validation plans and directed the outsourcing of technical projects,
product reliability, and UL compliance
Directed project managers in qualified methods to develop achievable project development plans
Supervised and coordinated the intellectual property (IP) portfolio of the company for three years
Co-authored the company product development process to conform with ISO 9001 quality system,
and FDA/GMP compliance
Varian Associates, Walnut Creek, CA
Sr. Mechanical Engineer
Principal mechanical engineer for an automated micro-sampler to Varian main Gas
Chromatography (GC) instrument product. Product is still in production.
Designed and tested new detector and high temperature injectors’ for lower cost systems, and
analyzed new generation high temperature ovens.
Developed a novel electronic MEMS gas flow controller to replace manual flow controllers.
Amer El-Hage
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1982 - 1987
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Developed and applied accelerated concurrent processes for development of engineering projects.
Beckman Instruments, Palo Alto, CA
Product Engineer
Mechanical engineer and fluid dispensing designer on two bimolecular instruments; a new DNA
synthesizer, and a Vapor Phase Protein Sequencer with a micro-autosampler.
Engineered Beckman Instrument first Laboratory robot "Biomek 1000" Photometric reader, micro
dispense tool, and developed consumables for product extension.
Responsible for successful transfer to manufacturing of a High Performance Liquid
Chromatography (HPLC) system
Executed a cost reduction program which resulted in more than $750K of documented savings
through new designs, second sources, and innovative assembly methods.
TRAINING (selected):
2004
2001
2001
2000
2000
1999
1997
1994
1993
1992
1991
1990
1989
SolidWorks basic user’s training - GEI technology
Project Management - Cadence Management Corporation
Micro-fluidics & micro-fabrication technologies – Small Talk conference course
Advanced management training - American Management Association
CCD Devices and Fluorescence Spectroscopy – SPIE course
Micro-machined sensors basics - (Sensors Expo Course)
Software Validation (QSR) - SPIE
Managing Multiple Projects - (Skillpath Seminars)
Pro/E user’s training - Parametric Engineering
Design control / FDA compliance - Stockwell
Design for Manufacturing (DFM) – IBM Industrial Consulting
Basic Project Management - American Management Association (AMA)
Statistical process Control (SPC)
PROFESSIONAL AFFILIATIONS:
Chair - American Society of Mechanical Engineers (ASME), Santa Clara Valley Section; Co-Chair
Microplate Standards Development Group Society of Bimolecular Sciences (SBS); Society of Optical
Engineering (SPIE); Member of SMEI Microfludics MEMS International Standards Task force, and
Association of Laboratory Association (ALA); Laboratory Robotics Interest Group (LRIG) -Bay area
PUBLICATIONS:
El-Hage, Chinn, “Vapor Surface Modification of Consumables used in Drug discovery” – Presentation
at ImTECH, Conference South San Francisco, May 2005
El-Hage, et al. “Development of a Second Generation Low Volume Microplate Matched to the
Confocal Optical Properties of Analyst AD and HT “– Presentation SBS Conference Vancouver,
September 2000
El-Hage, et al. “An Automation-Friendly, "Industrial Strength" Solution to Fluorescence, Fluorescence
Polarization, TRF Detection Needs in HTS”- Lab Automation 1998
El-Hage, et al. “Rapid Instrument Development”, IVD magazine full article, August 1996
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PATENTS: 13 US patents, and 2 international
LANGUAGES: English, Arabic, sufficient French, and Spanish.
EDUCATION:
M.Sc. Mechanical Engineering, University of California, Berkeley, California, 1980
B.Sc. Agricultural Engineering, Ohio State University, Columbus, Ohio, 1978
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