Development Product

Haojun Fu, Ph.D.

**** ***** **,

Naperville, IL 60565

630-***-**** abnxx5@r.postjobfree.com

www.linkedin.com/in/haojunfu

SUMMARY

A dynamic R&D professional with new product development and

commercialization experience in bio-medical devices, analytical instruments

and disposables for the life sciences. Proven ability to lead cross-

functional teams in advancing product innovations from conception through

development to production. Strong competence in developing high performance

team environments, leveraging resources through collaboration and

accountability, and utilization of technical leadership skills. Passionate

about aligning customer needs with technology solutions to deliver superior

customer benefits through creative problem solving. Inventor on 8 issued

and pending patents.

EXPERIENCE

HAEMONETICS CORP., Chicago, IL 2006 - present

A leading provider in the development and marketing of automated blood

processing and diagnostic products and technology innovations to customers

around the world.

Principal Scientist, Product Development (2012 - present)

R&D lead in the development and execution of next generation fully

automated immunoassay analyzer for clinical blood banking market.

. Conducted consumer research and market analysis that defined product

positioning and differentiation for a new automated blood analyzer

product line. Worked with marketing, regulatory and clinical personnel to

assure product specifications are maintained and accurate.

. Led design and validation of prototype instrument and disposables product

line. Managed product transition to manufacturing and development of

quality control system while overcoming the challenge of tight schedule

and staff shortage.

. Developed and managed budgets/work plans and prioritization of projects

that ensured deliverables were met on time, in compliance and within

budget.

. Conducted technology assessment and due diligence projects that enabled

company to make sound technology investment decisions.

Lead Scientist, Product Development (2008 - 2012)

Led an R&D team of scientists and engineers in the development of core

platform technologies for novel immunodiagnostic instruments and

consumables.

. Led research and development of a novel microfluidic chip based point-of-

care compact microscopic immunodiagnostic testing system that performs

accurate, rapid and cost-effective forward and reverse blood typing, with

true walk-away automation and all on a single disposable.

. Developed and validated a plasma separation instrument and disposable

cartridge for automated blood testing that reduced processing time by

75%. Developed disposable testing and validation programs that ensured

product quality and compliance with regulatory requirements.

. Developed and implemented an ultra-fast solid-phase ELISA assay

incubation system that reduced incubation time by 70%.

. Led research and development of next generation fluorescence-activated

cell sorter (FACS)/flow cytometer for ultra high throughput cell

screening. Designed prototype system and successfully licensed the

technology to business partner for commercial development.

. Established fluidic-disposable prototype lab. Developed and managed SOPs

for lab and instrument operations. Supervised and trained personnel on

projects and ongoing lab works.

Senior Scientist, Product Research and Development (2006 - 2008)

Provided technical leadership in new product innovation efforts with a

focus on the development and application of proprietary new technologies.

. Developed design, prototyping, testing, volume production and quality

control processes for bio-medical disposables used in in-vitro diagnostic

(IVD) instruments and other analytical instrumentation.

. Led development and implementation of liquid handling systems and fluidic

disposables for an automated microscopy based cell isolation and

screening system. Conducted feasibility studies and design reviews for

product development projects.

. Developed microfluidic solutions and integration strategies for portable

in-vitro diagnostics and point-of-care applications.

ARRYX INC., Chicago, IL 2005 - 2006

An award winning start-up Biotechnology Company committed to the

development and commercialization of innovative platform technology.

Scientist/Product Development Engineer

Held positions of increasing responsibility in product research and

development in a fast paced dynamic group.

. Contributed in new product development and expansion of existing product

lines. Led design, simulation, prototyping, testing, root cause analysis

and corrective action effort.

. Designed, prototyped and validated several optical-fluidic subsystems

used in continuous flow cell/particle recognition and manipulation for

integration with scientific and diagnostic devices using proprietary

Holographic Optical Tweezing and quantitative annotation technology.

. Led development of many instrument innovations, including a laser cutter

and a precision temperature control stage for live cell interrogation and

quantitative imaging. Designed, developed and validated product for

integration with customer configurations.

. Hands-on involvement across a wide area of responsibilities including

product training, troubleshooting, and customer care.

LEHIGH UNIVERSITY, Bethlehem, PA 2001-2005

Research Associate

. Led development of a laser based digital particle image velocimetry (PIV)

and force measurement system, allowing nonintrusive quantitative flow

characterization and control. Developed algorithm and software for motion

control, data/image acquisition and post-processing, and statistical

analysis.

. Designed and implemented novel fluidic systems for complex fluid flow

analysis using advanced optical diagnostic techniques. Developed and

studied an in vitro central venous catheter (CVC) model that provided

insight in product improvement and development of a new design

methodology.

. Conducted research in fluid dynamics in areas of complex flow

quantitative imaging and visualization, fluid-object interactions, flow

instability and control for multi-scale flow problems, with applications

in healthcare, engineering and environmental problems.

EDUCATION

LEHIGH UNIVERSITY, Bethlehem, PA

Ph.D., Mechanical Engineering and Mechanics 2004

SHANGHAI JIAO TONG UNIVERSITY, Shanghai, CHINA

M.S., Structural Engineering and Mechanics 1999

XI'AN JIAO TONG UNIVERSITY, Xi'an, CHINA

B.S., Engineering Mechanics 1996

PROFESSIONAL DEVELOPMENT

. Executive Education Management Certificate Programs (Kellogg School of

Management, Northwestern University)

. Verification and Validation - Product, Equipment, Software, and QMS

(Compliance Online, San Francisco)

. Leadership Development (Kellogg School of Management, Northwestern

University)

. FDA Regulatory Update and Best Practices for Compliance (MD&M,

Chicago)

. Serologic Problem Solving (Illinois Association of Blood Banks)

Haojun Fu PAGE 3

ADDENDUM

PATENTS

. Surface Mapping by Optical Manipulation of Particles in Relation to a

Functionalized Surface, US Patent 8169600, WO2008034102, EP2067035, CN

200*********, Issued May 2012.

. Particle Sorting Using Fluid Streams, Patent Application 201********,

Filed June 2009

. Methods and apparatus for detection of positional freedom of particles

in biological and chemical analyses and applications in

immunodiagnostics, Patent Application US2011/000930, Filed May 2011

. Methods and devices for immunodiagnostic applications, Patent

Application PCT/US2012/023553, Filed January 2012

. Centrifuge rotor for separation and processing of complex fluids,

Patent Application US2012/0202673, Filed January 2012

. Methods and devices for immunodiagnostic applications, Patent

Application 13/364,279, Filed February 2012.

. Method and apparatus for fractionating genetically distinct cells and

cellular components, Patent application PCT/US12/44011, Filed June

2012

. High-speed two-step incubation method and apparatus for in-vitro

diagnostic testing, Patent Application 61/652671, Filed May 2012

AFFILIATIONS

. Sigma Xi, The Scientific Research Society

. American Physical Society

. American Society of Mechanical Engineers

. American Association of Blood Banks

. Society for Laboratory Automation and Screening

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