Sun Kim ……Quality-by-Design Evangelist

Sun Kim

Sun Kim – Quality by Design for Pharma, Biotech, Medical Devices

Dr. Sun K. Kim is a Quality-by-Design Evangelist, transforming how Product Development is executed in the Biologics, Pharmaceutical and Medical Devices industry. In addition, he teaches at Keio University and Stanford University. His current focus of research is Quality-by-Design, Agile Development of Drugs and Therapeutics.

He received his MS and PHD in Mechanical Engineering at Stanford University. Sun was recently a Professor at Keio University in Japan. Prior to Silicon Valley days, he served in the Korean Army and worked at BMW in Munich, Germany

Sun Kim


Quality by Design – Founder


January 2013 – Present (2 years 6 months)

Founder of

Quality by Design for Biotech, Pharmaceutical and Medical Devices – Quality by Design Tools and Case Studies


Stanford University

2005 – Present (10 years)Stanford, CA

Teach Design for Manufacturing, Robust Design, Design of Experiments

Master Black Belt in Quality-by-Design, Lean Six Sigma, Sr. Manager

Bayer HealthCare

November 2012 – May 2015 (2 years 7 months)Berkeley, CA

Sr. Manager, Master Black Belt in Quality-by-Design, Design for Lean Six Sigma,
Leading Business Process Management

Design for Excellence Evangelist


March 2011 – November 2012 (1 year 9 months)

Master Black Belt (Lean Six Sigma), Project Management Professional, Scrum Master

Assistant Professor of Graduate School of Systems Design and Management Assistant

Keio University

March 2008 – March 2011 (3 years 1 month)

Lecture and advise graduate-level, professional students on system and product design, design thinking, creative brainstorming methodologies, prototyping, project management and business development. Solicited 15 industry project partners. Generated $35,000/year after developing non-degree curriculum for professionals. Co-Investigator of research projects of $50,000: Indoor Location-based Services Technology for Mobile Devices. Consults manufacturing companies (Hitachi, Toshiba) on growth strategies for Service Business Innovation. Others include developing cost simulation tool of product design based on injection molding, design for manufacturing and healthcare delivery systems. Began as a lecturer in Feb. 2008 to co-develop a project-based design curriculum, Active Learning Program Sequence (ALPS), educating over 100 graduate students every year.

Invited as an Assistant Professor in June, 2009.

Research, Teaching Assistant

Stanford University

September 2005 – June 2009 (3 years 10 months)

Lectured, coached and managed over 40 multi-disciplinary teams on Design for Manufacturing projects from Biomedical device (Medtronic, Maquet, St. Jude Medical, etc.) and automotive companies (Toyota, Nissan, GM, etc.). Served as the main research associate of Toshiba Corporation Six-Sigma Consulting Inc., developing systems design and manufacturing programs for Toshiba employees. Innovative projects were mobile personal-assistant IT system and agile transportation infrastructure.

Industry-sponsored Projects

Stanford University

September 2004 – June 2009 (4 years 10 months)

Maquet Cardiovascular: Coached and led a 3 member team in redesigning the crimping process of Hemashield Grafts, resulting in cost reduction of $75,000 and operators’ medical costs from injuries.

Satiety (Bariatric Surgery Device for Obesity Treatment) Design for Manufacturing Project: Coached a 3 member team in redesigning the packaging and supply chain for the Toga System, resulting in supply chain efficiency of 50% improvement by applying Lean and Errorproofing (Poka Yoke) Techniques.

Medtronic Vascular: Coached a 4 member team in redesigning the manufacturing line of a stent-graft, resulting in 73% reduction of lead time and increase in reliabilty and performance. Observed over 5 vascular and general surgery cases.

St. Jude Medical: Led a 4 member team in developing a 7-year supply chain strategy for new service centers of ICD/pacemaker programmers in Europe, Asia, N. and S. America and Oceania. The recommendation consists of an optimized cost model from net present value analysis and AHP location decision modeling that will save $461 million over 7 years and increase customer service rate compared to the existing service centers.

Nissan Motors: Led a 4 member team to construct a 20 year technology / business roadmap of Nissan Fuel Cell powertrain / vehicles which projects $ 4.8 billion revenue. Created a fuel cell vehicle concept design by applying Design for manufacturing tools including market research, manufacturability, and profitability analysis.

Zimmer Orthopedics: Implemented, with five team members, a FEA (finite element analysis) simulation tool with ABAQUS which assists in the development of treating knee osteoarthritis, based on MRI and gait data.

General Motors: Achieved potential cost reduction of $450 per vehicle and reduced 50kg of car weight by replacing wires with conductive coatings and RFID applications with a team of four members.

Design for Six Sigma Research Fellow


September 2005 – March 2009 (3 years 7 months)

Developed Design for Six Sigma Curriculum for Toshiba Corp.
Trained engineers, managers in systems design methodologies.
Coached Six Sigma projects.

Medical Device Design Innovation Program Developer

Johnson & Johnson

July 2007 – September 2007 (3 months)

Developed an innovation-incubation program to design/develop next generation product/technology with physicians and multidisciplinary design teams.

Design, Manufacturing Consultant

NeoGuide Systems

April 2006 – September 2006 (6 months)

Performed Robust Design, Design of Experiment, Developed manufacturing tooling, testing protocols and automated stations.

Reliability Research Assistant

Stanford Linear Accelerator Center

June 2005 – December 2005 (7 months)

Developed a reliability decision analysis tool for the LINAC System which will save $83 million per year on the $8 billion International Linear Collider Project. Enhanced reliability of the Accelerator system up to 20% and had increased throughput by linking Failure Mode and Effect Analysis of the Tuner to the evaluation tool.

Optimization/ Structural Analysis Intern

Samsung Electronics

February 2004 – February 2004 (1 month)

Improved impact-worthiness (20%) by optimizing design parameters of cell phone cases after performing structural analysis.

Design, Manufacturing Engineer


June 2003 – January 2004 (8 months)

Applied for 1 patent individually and created 3 design proposals as a team in 3 months. Saved $2,760 per month by implementing knowledge database management system. Resolved 3 process problems during 2 weeks of manufacturing
rotation program in Munich assembly plant with the manufacturing engineers.

US – ROK Army Radiology Tech, Company Leader, Manager

Republic of Korea Army

February 2000 – April 2002 (2 years 3 months)

Served 20,000 US Army patients as a Radiology Technician, tasks including diagnostic x-ray imaging, upper GI, etc. Managed 12 multi-national soldiers and a radiology department. Was awarded as “the accident-free company.” Increased the availability of the radiology department, which takes care of 20,000 patients, up to 130% by building a forecast schedule planning system.



Stanford University

Stanford University

Ph.D, Mechanical Engineering

2006 – 2009

Focus in Systems (Product, Service, Business) Design, Design Thinking, Design for Manufacturing and Six Sigma

Activities and Societies: Design SocietyASMEIEEEINCOSEACM

Stanford University

Stanford University

MS, Mechanical Engineering

2004 – 2006

Focus in Biomedical Device Design, Reliability Engineering, Operations Research

Activities and Societies: KOSEF Academic Fellow


A New Project-Based Curriculum of Design Thinking with Systems Engineering Techniques

International Journal of System of Systems Engineering


Agile Project Management for Root Cause Analysis Projects

International Conference on Engineering Design


A New Project-Based Curriculum of Design Thinking with Systems Engineering Techniques

Council of Engineering Systems Universities


Evaluation of Design for Service Innovation Curriculum: Validation Framework and Preliminary Results

nternational Journal of Services Technology and Management


A Validation Regarding Effectiveness of Scenario Graph

ASME International Design Engineering Technical Conferences


Wants Chain Analysis: Human-centered Method for Analyzing and Designing Social Systems

International Conference on Engineering Design


Scenario-based Amorphous Design (SAD) Framework for a Location-based Services Technology

Mobile Human Computer Interaction


Transforming Seamless Positioning Technology into a Business using a Systems Design Approach—Scenario-based Amorphous Design

IEEE- International Systems Conference


Design for Service Innovation: A Methodology for Designing Service as a Business for Manufacturing Companies

International Journal of Services Technology and Management


Preliminary Validation of Scenario-based Design for Amorphous Systems

International Conference on Systems Engineering


Tools for Project-based Active Learning of Amorphous Systems Design: Scenario Prototyping and Cross Team Peer Evaluation

ASME International Design Engineering Technical Conferences


Active Learning Project Sequence: Capstone Experience for Multi-disciplinary System Design and Management Education

International Conference on Engineering Design


Demystifying Ambiguity in The Design of Amorphous Systems

International Conference on Systems Engineering


Scenario-based Design for Amorphous Systems

ASME International Mechanical Engineering Congress and Exposition


Analysis and Design Methodology for Recognizing Opportunities and Difficulties for Product-based Services

Information Processing Society of Japan (IPSJ) Journal


Scenario Graph: Discovering new business opportunities and Failure Modes,”

ASME International Design Engineering Technical Conferences


Analysis and Design Methodology for Product-based Services

Annual Conference of the Japanese Society for Artificial Intelligence


Analysis and Design Methodology for Recognizing Opportunities and Difficulties for Product-based Services



Sun Kim

About QbDWorks…

Are you a Scientist in the Pharmaceutical, Biopharmaceutical or Medical Devices industries?

Then you are probably asking:

  • Does Quality-by-Design actually work?
  • Or is it just another program like Lean or Six Sigma?
  • How do I implement QbD successfully?
  • How do I persuade my management?
  • What is the first step?

As a QbD practitioner, I had the same questions and am trying to answer them as I test different elements of QbD.

Through our members’ successes and failures in QbD, you can save time by not having to repeat them yourself. There are many lessons learned and knowledge that you can share with your QbD team.

Who are You?

Sun Kim

My name is Sun Kim. I currently practice Quality-by-Design, transforming how Product Development is executed in Biopharmaceutical, Pharmaceutical, Biologics, and Medical Device industries.

In addition, I teach at Stanford University. My focus of research is Lean Quality by Design.

I received my MS and PHD in Mechanical Engineering at Stanford University and was recently an Asst.  Professor at Keio University in Japan. Prior to Silicon Valley days, I served in the Korean Army and worked at BMW AG in Munich, Germany, where my lifelong pursuit of “Product Development Methodology” began.

Why is an Engineer working in the Bio/pharmaceutical Industry?

Thanks for asking! When working at BMW, as a member of the elite “KREATIV” (Creative) team, my goal was to develop the best technologies and products for the automotive industry. However our approach was somewhat adhoc and heuristics-based. I knew there was a better way.

So I set my heart to learn how best products are developed across all industries. This led me to my PhD research at Stanford University.

Little did I know this would turn out to be more than just a graduate program. On top of the typical coursework, research and publishing, my schedule was packed with hands-on consulting/research projects with GE Healthcare, GE Aviations, Toyota, Nissan, Toshiba, Medtronic, Johnson & Johnson, Startup’s etc.

After contributing to the product development approaches for the Academia, Fortune 500 and Startup’s, I knew my heart was always with Health Care. So I returned to the benches and trenches.

For the last 10 years, I have been working in the Biopharmaceutical, Pharmaceutical and Medical Devices Industry, to make Quality by Design a reality.

So please join me in this Quality by Design journey.

Sign up to connect to the community and receive updates.

Together, we can change how drugs and therapies are developed for our patients and families.

Let’s Connect!

If you’d like to connect, please invite me:

Previously I worked (full time or consulting) with:

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The views expressed on this website are personal opinions and in no way reflect the position of any organization.

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