Kife Chuang, 莊凱富

Medical device engineer with experience in different aspects of R&D including testing, TMV, Design Input/Output, Design Verification experience. Well-known for handling the projects by developing constructive working relationships with internal and external stakeholders.                                Pursuing a new role where hard work and dedication will be highly valued with the Mechanical Engineering knowledge for the product.

  Taipei, Taiwan     [email protected] +886981890281   https://www.linkedin.com/in/kife-chuang/

WORK EXPERIENCE

Verification Engineer  •  SHL Medical

March 2020 - Present

  1. Act as a Design Verification Test Leader to lead testing/validation relevant issue for 6 medical Auto-Injector projects throughout the engineering and mass production phase
  2. Own Design Verification & Test (V&T) on product development, design change, and CAPA projects, providing objective evidence that all Design Input Requirements (DIRs) were met and that final device design conforms to user needs and intended uses while following relevant design control procedures.
  3. Designs develop and validate testing methods and equipment. Plans and arranges the labor, schedules, and equipment required for testing and evaluating standard and special devices.
  4. Develop 50 testing working instructions and cosmetic standards for medical injectors to meet the QMS
  5. Response to be the trainer of the testing process, support the training for FQC and IPQC.
  6. Cooperate with project team across the United States, Sweden, and Taiwan to establish the medical testing standard and scope of a project such as force test, aging test, etc.

Test Engineer  •   SHL Medical

August 2019 - February 2020

  1. Performed rapid prototyping and deployment testing of components to evaluate the effect on the overall design.
  2. Supported Design Verification efforts by developing and validating test methods for meeting human factors and design input requirements.
  3.  Worked to meet the team's target for fixture bring up and testing UPH, and drive the testing issue would be fixed in time.

Intern — Assistant R&D Engineer  •  Opto Technology, LTD

July 2014 - August 2014 

  1. Assisted LED engineering development process for the edge LED back-lit modules.
  2. LED Optical characterization measurements and evaluation support.
  3. Coordinated with cross-functional teams to develop the sample for the LED backlight products. 

SPECIALTIES

Software

  • LightTools
  • SolidWorks
  • MS Office
  • Minitab 
  • Bluehill
  • CF Design

Hardware

  • Tensile/Compress Equipment
  • Reliability, Environment Testing 
  • Integrating Sphere
  • Illuminometer

Regulation

  • ISO 14971:2019 Academy Certificated
  • EN ISO 11608-1
  • ISO 11608-5


Language

  • Chinese
  • English
  • Mandarin

EDUCATION

Chang Gung University — Mechanical Engineering                     September 2015 - June 2017

MASTER OF MECHANICAL ENGINEERING — ELECTRONIC/ OPTICAL PACKAGING LAB

  • Master thesis 
    • Measurement and Simulation of Thermal and Optical Behaviors for Motorcycle LED Headlamp Packaging Modules 
  • Presenter & Co-Author 
    • Failure and Stress Analysis of Through-Aluminum-Nitride-Via Substrates during Thermal Reliability Test for High Power LED Applications (2016 EMAP Conference)
  • Chief of Master Student Association of Mechanical Engineering Department

Chang Gung University — Mechanical Engineering                     September 2011 - June 2015

BACHELOR OF MASTER OF MECHANICAL ENGINEERING 

  • Representative of Chang Gung University - National Affairs Conference on Trade and Economics 
  • Chief of Student Association of Mechanical Engineering Department
  • Chief of Public Relations Dept. of Students’ Association
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