Da-Yu Chang

• 1 invention disclosure
• Carpentier-Edwards Physio II Annuloplasty Ring System with Progressive Etiology Design™ (Class II medical device):
  • Design Control related project documentation, including project plan, verification & validation plan, risk management plan, and risk management report (per ISO 14971:2007).
  • Process development of resistance welding of multi-layer Elgiloy bands.
  • Resistance welding fixture and inspection gauges design.
  • Generate engineering drawings and manufacturing SOPs.
  • Write and supervise the execution of design verification protocols and reports .

• Intraocular Lens (IOL) Injection System (Class II medical device):
  • 2 invention disclosures
  • Product Design-Change project leader:
    • Author & maintain Design History File for new products, and update DHF for current products in accordance with current 21 CFR 820.30 Design Control and ISO 13485:2003 quality system regulations. Activities include revising product specification, risk analysis and management (per ISO 14971:2007), etc.
    • Update engineering drawings, manufacturing SOP, quality control SOP, device master records (DMR), and other related documentation.
    • Write and supervise the execution of design and process validations and reports. Employed ANSI/ASQ Z1.4-2003 sampling plans.
  • New IOL injector system designs (injectors and cartridges)
  • CAPA (Corrective And Preventive Action) project leader:
    • Evaluate product complaints received by post-market surveillance department. Categorize complaints and compare with historical trending.
    • Working with quality engineers to perform root cause analysis (RCA). Identify and confirm root causes through experimentations and simulations. Use results from experiments to substantiate Health Risk Assessment (HRA).
    • Propose and implement corrective actions, such as revising engineering drawings, manufacturing and quality control SOPs, Direction For Use (DFU), etc. to clarify or strengthen instructions.
  • Assess product performance in the field. Gather and evaluate feedback from physicians and sales representatives on product usage for future design optimizations or new product development.
• IOL Optics Design (Class III medical device):
  • Assist optical engineer in lens optics design. Confirm and update diopter calculation algorithm. Confirm CAD/CAM modeling with theoretical values.
  • Design inspection fixtures for the measurements of optical and mechanical properties of IOL and ICL.
• Participate in regulatory and quality (ISO 13485:2003) compliance related activity. Interacted with FDA inspectors, and contributed to a successful FDA audit.
• Identify potential Intellectual Property infringement by competitors, and present evidence to outside patent counsel.

• Argus Implantable Retinal Prosthesis (IRP) Systems (Class III medical device):
  • 2 U.S. patent issued, 3 patents pending and 3 invention disclosures.
    • U.S. patent No. D565082
    • U.S. patent No. 7228181
    • U.S. patent application publication No. 20080154336 / 20080154337
    • U.S. patent application publication No. 20050222624 / 20060271189 / 20080039936 / 20080039938
    • U.S. patent application publication No. 20060253124 / 20070093852
    • WIPO patent application publication No. WO/2008/079171
    • WIPO patent application publication No. WO/2008/020849
  • Investigate and evaluate various mechanical design criteria and feasibility of the IRP system, based on physiological requirements and current technological limits.
  • Assess and experiment with prototype components, and optimize their designs through physician feedback, pre-clinical and clinical trials conducted at the Doheny Eye Institute.
    • Design, styling, and prototyping of enclosure for external electronics and physical user interfaces (Project Leader)
    • Design and prototyping of experimental surgical instruments
      • Development of novel device attachment method (Project Leader)
    • Design and prototyping of IRP related manufacturing fixtures and processes:
      • Develop Nd:YAG laser welding of hermetic package (Project Leader)
      • Fixtures for thermoforming the implantable thin-film polyimide electrode array
      • Fixtures for injection/transfer molding of platinum-silicone electrode array
    • Design fixtures for thin-film deposition (HV/UHV)
• CAD system administrator / PC administrator
• Company intranet web site design