1. CELESTE FRALICK
celeste.r.fralick@intel.com or crfralick@ymail.com
Office: 480-554-0248 Cell: 480-734-7499
SUMMARY OF EXPERTISE
Strategic, out-of-the-box thinker with strong analytic, system engineering, product/process development
and process improvement skills. Chief Data Scientist of >$2B org. Multi-tasks well, drawing on broad
experience of analytics, engineering, disability analyses, risk management, operations, quality systems,
global regulatory affairs, clinical management, biotechnology, and reliability. Cross-industry
recognized for ideation, strategic leadership, and results-oriented skills. Senior technical leader in
Fortune 100 Company with analytic, software, and hardware product development experience.
PROFESSIONAL EXPERIENCE
Intel Corporation 1995 – present
Chandler, AZ
Principal Engineer, Chief Data Scientist (2013 to present)
• Develop complex algorithms and models for embedded market segments enabling $2B in 2014
revenue, inclusive of Diagnostic and Predictive analytics, utilizing JMP, MatLab, and translation to
software
• Utility –centric strategic analytic continuum developed and deployed with $5B customer
• Lead Intel-wide Analytic Center of Excellence (>120 analysts), developing education, Product Life
Cycle/Agile development for analytics, product portfolio for $60B company
• Developed automated data scientist concept, including patents, product development, and support of
Smart Data Pipe
Principal Engineer, Staff Architect (2011 to 2013)
• Oversaw technical and strategic hardware and software architecture for embedded industries,
including medical, industrial, gaming, printing, digital security and surveillance, retail
• Led 32 global hardware and software architects in technical leadership pipeline
• Enabled and defined software analytics embedded solution for intelligent systems
• Delivered predictive maintenance analytics solution with greater than .90 R-square (90% model fit)
• Defined and delivered medical regulatory continuum to enable mobile, tablet, and embedded
markets
• Provided detailed industrial use cases for human machine interface and end-to-end embedded
solutions (edge to gateway to cloud)
Principal Engineer, Director of Biomedical Engineering (2005 to 2010)
• Led a Biomedical Engineering Center of Excellence for telemedicine and assistive products
• Various Managed virtual cross-functional team for exploration (market analysis), development, and
implementation of medical device peripherals for telemedicine platform. Team includes marketing,
software, hardware, supplier management, verification, and validation personnel.
• Developed and implemented 5 year roadmap for medical peripherals, 10 year roadmap for iNEMI.
• Manage vendors, supply chain, qualification & regulatory submission.
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2. • Develop telemedicine design and clinical protocols, patent reviews, and analyses for
biocompatibility, field failures, risks and hazards. Strong focus in statistical and pattern recognition
analyses.
• Team member to develop first Intel regulated medical device for remote monitoring, team lead for
insuring device was Continua software certified
• Insured global compliance to regulatory requirements, including clinical investigations, ISO 13485
and QSR auditing, FDA 510(k) submission for U.S. Class II, and CE mark requirements in EU and
Asia for MDD Class I. Director of Regulatory Affairs during two year start-up.
• Delivered disability compliance analyses for three healthcare products
Quality Technology Research Manager / Q&R Pathfinding/Research Scientist (2003 to 2005)
• Enabled breakthrough solutions via research and analyses of engineering advances primarily in the
area of Quality and Reliability. Collaborated across multi-functional organizations. Acted as change
agent. Grew business by 15% in 2004. Projects included:
U.S. NSF-supported national consortium report on “Technology Convergence”
Capability Maturity Model Integration and SPC in Software Development
Globalization Impact on the Semiconductor Market
Systems/process analysis (Six Sigma) in Product Regulations and Corporate Risk
Intel Nanotechnology Safety Review Board member
Intel Capital Q&R Engagement Process and Biotechnology engineering support
Benchmarking of Quality Management Systems
Applying Microarrays to Neurophysiology & UWB RF Effects on Neuronal Membranes
Developer of 2-day Quality 101 class for Intel Employees
Six Sigma/ISO state-of-the-art, European biotech marketing strategies, and executive staff
biotechnology briefings
Product Quality Systems and Operations Manager / Technical Assistant (1998 to 2003)
• Developed Intel product qualification system with supporting knowledge management database
• Developed Intel Quality Management System
• Developed corporate Risk Management specification
• Key developer in 2000 Intel Biotechnology Strategy, including patent & capital investigations
• Consulted and drove completion of $65M Strategic Planning for Arizona Biodesign Institute
• Corporate Statistician (esp. Design of Experiments)
• Provided Quality Systems solutions to wireless and communications Q&R groups globally
• Responsible for budget, headcount, presentations, strategic plan as Director’s technical assistant.
• Developed and co-managed global product development quality and reliability network, including
All of Intel components, boards, systems, and software
Steering Committee logistics and strategic planning across all groups, including strategic
capability segments and associated roadmaps, pathfinding funds
Product Quality Manager – Embedded Microcomputer Division (1996 to 1998)
Developed, qualified, and transferred 286/386/486 embedded product devices
Developed quality transfer system (development to manufacturing)
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3. Led qualification and customer return failure analysis and review boards
Assessed and managed third party suppliers and drove in-house process improvements
Fab Quality Manager (1995 to 1996)
Developed corporate failure modes effects and analysis process (FMEA) and documentation
Developed & deployed material review board process and documentation
Led failure analysis and review boards for returned product or in-line review boards
Medtronic, Inc. 1988 - 1995
Tempe, AZ
Semiconductor Operations Product Assurance Manager
Managed over 50 custom monolithic, hybrid, and module programs insuring quality and reliability in
process and product from customer introduction to shipment. Military, medical, and commercial
applications. Bipolar, CMOS, BiMOS, BICMOS,
Program chair for Gate Oxide Enhancement, realized $1M savings. Member SPC CAT, corporate
Wafer Level Reliability committee, Technical Review Board for Fab Processes. Performed Mil Std
883, ISO, FDA audits, certified and qualified site to Mil Std 1772 via Mil Std 1553 SMD. Site
JEDEC rep. First MIL approved TAB packaging across 3 sites.
Developed qualification and reliability monitor program and laboratory. Reduced 22 fab gates to
monitor/audit program. Created incoming QC and RMR system. Determined and corrected EOS
failure mechanism resulting in shipment of 4 products. Approved all fab, assembly, and test
changes. Four departmental budgets and planning responsibilities.
National Semiconductor / Fairchild Semiconductor 1985 to 1988
Santa Clara, CA
Divisional Product Assurance Manager
Promoted to oversee quality and reliability of Mil Std 1553 microcontroller, NMOS/PMOS
commercial product. Qualification system netted $5M savings. Certified process and product to Mil
Std 883. Coordinated and approved all product changes, process developments. Handled RMRs,
line inspections, audits, military program management. Supervised management, engineering, direct
labor staff.
Fab Quality Control Manager
Responsible for incoming silicon, masks, chemical analysis, and in-line wafer fabrication QC and
associated laboratories. Led Juran quality teams and contamination task forces reducing defect
levels 70%. Developed ship-to-stock programs. Supervised engineering and direct labor staff.
Assembly/Test Quality Control Manager
Responsible for inspection and engineering quality staff of a JAN certified memory and logic line.
Development and maintenance of qualification program. Created parallel inspection techniques,
customer source inspection unit. Supervised direct labor and engineering team.
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4. Texas Instruments 1980 – 1984
Dallas, Texas
QRE Engineering Manager
Promoted to initialize and sustain qualification of the 74HCMOS. Performed competitor
evaluations. Member of CMOS ESD corporate design team.
QC Fab Engineering Supervisor
Promoted to supervise all QC inspectors. Engineering extended from backgrind and sort to include
metal and glassivation. Developed real-time QC feedback programs to manufacturing and off-shore
assembly sites using Statistical Process Control. Supervised 50 direct labor and engineering
personnel.
QC Fab Engineer
Coordinated fab quality control sites with off-shore assembly sites. Defined and implemented
divisional QRE specifications, inspections, and diagnostics. Supervised technical staff.
EDUCATION
PhD, Bioengineering (analytics, neuroscience, bioelectricity): Arizona State University, May 2013.
(Dissertation :) “A Statistical Clinical Decision Support Tool for Determining Thresholds Using
Predictive Analytics”
MSE, Bioengineering/Bioelectricity: Arizona State University, 1998
Bachelor of Science, Microbiology/Chemistry: Texas Tech University, 1980
umerous MBA and company classes completed throughout career – available upon request.
PROFESSIONAL AFFLIATIONS AND HONORS
International Institute of Analytics, research faculty (2010 to present)
Texas Health Services Authority, Technology Workgroup (2010)
Arizona Governor’s Commission on e-Health - Steering Committee, Technical Task Group
(Governor appointment, 2005-2006) and Health-e Connection Advisory Board (2007 to 2013)
Board of Directors, International Essential Tremor Foundation (2007 to 2012)
Advisory Board, ASU WinTech (BioMEMS) (2006 – 2008)
Advisory & Executive Board, ASU College of Nursing Health Innovation and Clinical Trials (2006
to present)
Ethics Advisory Board, White House Office of Science & Technology (2006)
Co-chair, 7th
World Nanotechnology Conference featuring Digital Health (2005-2006)
Chair, ASQ AZ Biomedical Discussion Group (2005)
Editorial Board, Journal of Biomedical Devices (2004 to present)
Nominated “Emerging Leader, Society of Women Engineers”, 2005
Intel Science and Engineering Fair Judge (2004, 2005, 2006)
American Society of Quality Senior Member (2003) and Executive Committee, Phx Chapter
Intel Division Recognition Award (2003, Qualification System Re-engineering)
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5. Intel Leadership Breakthrough Award (2002, Quality Management System)
Intel AZ Cultural Leadership Award (2002)
Intel Mentor Award (2001)
Intel Division Recognition Award (2001, Strategic, Financial, and Pathfinding Processes)
Intel Outstanding Team Contribution (2000, Quality Operating System)
Intel Division Recognition Award (1997, Embedded Microcontroller Division)
Medtronic Scholarship Recipient (1995)
Medtronic Professional Honors Recipient (1989)
Medtronic Star of Excellence nominee (1990)
Chair (1995-1998), Vice-Chair (1993-95), Member (1991-2005) JEDEC JC-13, led
JEDEC/EIA/MIL-STD/MIL-PRF specification developments teams on Residual Gas Analysis, SPC,
Process Characterization, and Tape Automated Bonded packaging.
Member ICWG on VLSI/VSLIC, SQC/SPC (1981-1983)
Member of Electronics Industry Association Q & R Engineering, developer of EIA 599.
Scientific Advisory Board of Directors, Arizona Biodesign Institute
Board of Directors, Arizona State University Bioengineering Advisory Committee
Board of Management, Ahwatukee Foothills YMCA
Member, Scientific Advisory Board for 6th Targeted Nanodelivery for Therapeutics and Molecular
Imaging (2005)
Member, iNEMI TIG Medical Grade Reliability Workgroup (2005 to present)
Founding member, Alpha Eta Mu Beta (Bioengineering Honor Society), ASU
Member, Biomedical Engineering Society (BMES), Society of Women Engineers, IEEE, and
Regulatory Affairs Professionals Society
Member, IEEE, Informs, Intel Virtual Factory Statisticians
SELECTED PAPERS / POSTERS / INVITED TALKS / BOOKS
“Intelligent Analytics” Fralick, Celeste and Sarah Kalicin, Apress Publishing. In development.
“Analytics 101” – various audiences, internal and external, including IEEE, Intel Women’s PE and
Fellows Conference
Grace Hopper 2014 “A Statistical Clinical Decision Support Tool for Determining Thresholds Using
Predictive Analytics”
Texas Tech University Society of Women Engineers “Shaping a Woman’s Engineering Career”
(2011)
U.S. Buyers Delegation to Canada (2010)
Panelist, Context Aware Computing, BodyNets Conference (2008)
“The Imminent Revolution of Medical Electronics”, keynote, Surface Mount Technology
Association (2008)
“The Engineer of 2020”, panelist, Society of Women Engineers (2007)
“Workplace Mentoring”, panelist, Grace Hopper Celebration of Women in Computing, Anita Borg
Institute for Women and Technology (2007)
“The Future of Biotechnology”, keynote address, MEPTEC (2007)
Fralick Resume 5
6. “The Future of Medical Technology”, Technology Forecasters, Quarterly Forum for Electronics
Manufacturing Outsourcing and Supply Chain (2007)
“Supply Chain Challenges in a Convergent Technology”, Stanford University, Global Supply Chain
and Manufacturing in Emerging Economies (2007)
“Strategic Innovation in a New Platform”, Supply Chain Leaders Forum (2007)
“Birth of a Platform”, WestBEC (2006) and Northwestern Kellogg School of Business (2006)
“Televisions in our Refrigerators, Cameras in our Phones: The Convergence of Computer Chips and
Biotechnology”, American Association of University Women, Puyallup, WA (2006)
“Evolution of an AEMB-Led Ethics Session for the BMES Fall Meeting” Poster (BMES 2006
Meeting)
“Convergence of Biotechnology and Semiconductors”, MEPTEC (2006)
“Value Proposition of Medical Grade Components” NIST/FDA Measurement Methods for the
Reliability of Actively Implanted Devices (October 2005)
“Hidden Risks of Convergent Innovation,” Intel Technical Leaders Conference, 2005
“Improving Quality Using Business Acumen”, ASQ Congress (May 2005), Albuquerque Section
(Sept 2005), Phoenix Section (Nov 2005)
“Business Acumen in the Quality Profession”, Arizona Quality Alliance (2004)
“Bioethical Challenges of Digital Health,” BMES National Conference (Oct 2005)
“Risk Management in Innovation”, MATI think tank/consortium (2003)
“Hidden Risks of Integrating Risk Management” MATI (2003)
“Effects of Higher Resistivity on Gate Oxide Integrity), International Wafer Level Reliability
Symposium (1989)
“High Reliability in Tape Automated Bonded Packages” presented at AMLCD Conference (1990)
Numerous ASU MBA and Engineering invited talks (1988 – present)
Intel IMEC Submissions (2005: Translational Quality – Juggling the Many Requirements of
Industry, Risk Management in Innovation; 2006: DHeG Biomedical Engineering Implications to
TMG)
Britton, Steven L, Lorenz O. Lutherer, Donald O. Davies, “Effect of cerebral extracellular fluid
acidity on total and regional blood flow,” J. Appl. Physiol, 1979,Vol. 47, pp. 818-826 (technical
assistance, Texas Tech School of Medicine)
PROFESSIONAL CERTIFICATIONS
CA and AZ Quality Award State Examiner (Malcolm Baldrige criteria) (2004)
ISO 9001:2000 RAB Nationally Certified Auditor (2003 to present)
American Society of Quality Certified Quality Auditor (CQA) (2003 to present)
PATENTS
• Automated Data Scientist – Patent Pending
Fralick Resume 6
7. “The Future of Medical Technology”, Technology Forecasters, Quarterly Forum for Electronics
Manufacturing Outsourcing and Supply Chain (2007)
“Supply Chain Challenges in a Convergent Technology”, Stanford University, Global Supply Chain
and Manufacturing in Emerging Economies (2007)
“Strategic Innovation in a New Platform”, Supply Chain Leaders Forum (2007)
“Birth of a Platform”, WestBEC (2006) and Northwestern Kellogg School of Business (2006)
“Televisions in our Refrigerators, Cameras in our Phones: The Convergence of Computer Chips and
Biotechnology”, American Association of University Women, Puyallup, WA (2006)
“Evolution of an AEMB-Led Ethics Session for the BMES Fall Meeting” Poster (BMES 2006
Meeting)
“Convergence of Biotechnology and Semiconductors”, MEPTEC (2006)
“Value Proposition of Medical Grade Components” NIST/FDA Measurement Methods for the
Reliability of Actively Implanted Devices (October 2005)
“Hidden Risks of Convergent Innovation,” Intel Technical Leaders Conference, 2005
“Improving Quality Using Business Acumen”, ASQ Congress (May 2005), Albuquerque Section
(Sept 2005), Phoenix Section (Nov 2005)
“Business Acumen in the Quality Profession”, Arizona Quality Alliance (2004)
“Bioethical Challenges of Digital Health,” BMES National Conference (Oct 2005)
“Risk Management in Innovation”, MATI think tank/consortium (2003)
“Hidden Risks of Integrating Risk Management” MATI (2003)
“Effects of Higher Resistivity on Gate Oxide Integrity), International Wafer Level Reliability
Symposium (1989)
“High Reliability in Tape Automated Bonded Packages” presented at AMLCD Conference (1990)
Numerous ASU MBA and Engineering invited talks (1988 – present)
Intel IMEC Submissions (2005: Translational Quality – Juggling the Many Requirements of
Industry, Risk Management in Innovation; 2006: DHeG Biomedical Engineering Implications to
TMG)
Britton, Steven L, Lorenz O. Lutherer, Donald O. Davies, “Effect of cerebral extracellular fluid
acidity on total and regional blood flow,” J. Appl. Physiol, 1979,Vol. 47, pp. 818-826 (technical
assistance, Texas Tech School of Medicine)
PROFESSIONAL CERTIFICATIONS
CA and AZ Quality Award State Examiner (Malcolm Baldrige criteria) (2004)
ISO 9001:2000 RAB Nationally Certified Auditor (2003 to present)
American Society of Quality Certified Quality Auditor (CQA) (2003 to present)
PATENTS
• Automated Data Scientist – Patent Pending
Fralick Resume 6