Amer El-Hage

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 -PresentBeeston 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 compliancewith ISO, CE and FDA regulations.

2000-2004Molecular 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.
  • Coordinatedconcepts and design reviews, verification, reliability and life testing of new products
  • Developed and released an updated MDC Product Development Process for ISO Design Control.

1991- 2000LJL 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 tobuild 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

1987- 1991Varian Associates, Walnut Creek, CA

Sr. Mechanical Engineer

  • Principal mechanical engineer for an automated micro-sampler toVarian 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.
  • Developed and applied accelerated concurrent processes for development of engineering projects.

1982 - 1987Beckman 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):

2004SolidWorks basic user’s training - GEI technology

2001Project Management - Cadence Management Corporation

2001Micro-fluidics & micro-fabrication technologies – Small Talk conference course

2000Advanced management training - American Management Association

2000CCD Devices and Fluorescence Spectroscopy – SPIE course

1999Micro-machined sensors basics - (Sensors Expo Course)

1997Software Validation (QSR) - SPIE

1994Managing Multiple Projects - (Skillpath Seminars)

1993Pro/E user’s training - Parametric Engineering

1992Design control / FDA compliance - Stockwell

1991Design for Manufacturing (DFM) – IBM Industrial Consulting

1990Basic Project Management - American Management Association (AMA)

1989Statistical process Control (SPC)

Professional Affiliations:

Chair - American Society of Mechanical Engineers (ASME), Santa Clara Valley Section; Co-Chair Microplate Standards Development GroupSociety 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 toFluorescence, Fluorescence Polarization, TRF Detection Needs in HTS”- Lab Automation 1998

-El-Hage, et al. “Rapid Instrument Development”, IVD magazine full article, August 1996

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, OhioStateUniversity, Columbus, Ohio, 1978

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