Wei Cai


Consultant


Professional engineering executive with solid technical and compliance knowledge, experienced in FDA, TUV, and UL requirements, skilled in medical device design and development, manufacturing process and equipment design and development, product and process verification and validation, new product introduction, technology transfer of product and assembly lines, manufacturing automation, product and process continuous improvement, lean manufacturing, and project management. Highly credentialed with years of experience in global medical device manufacturers. Background in surgical and medical instruments, medical diagnostic apparatus, hospital diagnostic equipment, whole blood oximeters, data connectivity, microcoagulation systems, incision devices, platelet reactivity systems, electrical packaging for tunable lasers, electromechanical sensors, and automated surgical stapling devices.

CORE COMPETENCIES

  • Project Management
  • Product Development
  • Design Controls / Change Controls
  • Design History Files
  • Design Inputs / Design Outputs
  • Design Verification / Validation
  • Package Design and Validation
  • Design Changes and Design Transfers
  • Risk Management / FMEA / Hazard Analysis
  • Design Reviews
  • Process and Equipment Development
  • Equipment and Process Validation (IQ/OQ/PQ)
  • Test Method Validation
  • Production and Process Control
  • Change Management
  • Product / Process Improvements
  • Product / Process Transfers
  • Lean Manufacturing/Continuous Improvement
  • Identification and Traceability
  • Labeling and Packaging Control
  • Preventative Maintenance
  • Nonconforming Handling
  • Corrective and Preventative Action
  • Complaint Investigations
  • Statistical Analysis and Process Control
  • Supplier Qualifications
  • FDA Inspections/Remediation
  • ISO Audits/Gap Analysis/Internal Audits

SELECTED ACCOMPLISHMENTS

  • Developed two generations of the microprocessor-controlled, handheld, powered medical stapling devices and consumables, including 6 product families, 25 product extensions and accessories to reduce surgical time and improve patient safety:
    • Created and executed design and development plan, managed the projects from concept to commercialization; improved and streamlined product development process, drove projects to completion on time, within budget and in compliance with FDA regulation.
    • Led and managed design activities, including design input, risk assessment, product design, product verification / validation, manufacturing process and equipment development and qualification (IQ/OQ/PQ) and product launch; managed design history files (DHF) and organized cross-functional design reviews.
    • Provided product post commercialization supports, utilized the Voice of the Customer process to capture the requirements / feedback from customers to improve existing product quality and create new product concepts.
    • Participated in creating regulatory strategy and assisted in device 510K submissions (Class 1, Class 2 and Class 3).
  • Process developed and implemented manufacturing launch strategy for new product introduction and technology transfer:
    • Established manufacturing capability in a startup company; consolidated critical OEM supplier operations to in-house manufacturing.
    • Developed quality plans in the early product development stage to assure congruence with manufacturing strategy and quality and regulatory requirements.
    • Initiated and implemented automation strategy in early design stage, defined URSs (User Requirement Specifications) and led design and qualification of automated assembly machines.
    • Created and implemented manufacturing strategy for new product introduction and production scale-up; led new process and equipment development, created SOPs, Process Maps, Device History Records (DHR) and other production document, developed and executed process and equipment validation Plans (IQ/OQ/PQ) to ensure manufacturing readiness.
    • Established and managed pilot manufacturing operations to ensure smooth product and technology transfer from R&D to manufacturing operation.
  • Initiated and implemented key elements of manufacturing operations and strategy:
    • Drove continuous improvement by utilizing Lean, Six Sigma and Kaizen principles; Created and monitored manufacturing operation metrics to continuously identify, improve and track results of opportunities to eliminate waste of all kinds.
    • Created and implemented multi-year manufacturing automation strategy to improve safety, product quality and reduce labor costs; managed $3MM annual capital budget for manufacturing operations, improved in-process yield by 7% in a year and saved $500K annually in direct labor.
    • Created and executed strategy to manage electrical part obsolescence in instrument manufacturing and instrument service operations to sustain legacy instrument product lines.
  • Developed quality management system, highly experienced with FDA regulations, ISO, UL requirements; assisted materially in raising compliance and clearing FDA Warning Letter; participated in FDA inspection and facilitated TUV and UL audits:
    • Established and co-chaired Validation Review Board (VRB) at multiple companies to provide verification / validation strategy for product, process and equipment qualifications; Reviewed and approved verification / validation protocols and reports to ensure compliance.
    • Co-chaired Change Review Board (CRB) to control design, process and quality policy changes; reviewed and approved all change initiations, change justifications (verifications / validations) and risk assessments according to company procedures and in align with regulations.
    • A member of quality steering committees to review and approve CAPA initiations, CAPA investigations and mitigations and effectiveness verifications to ensure the effectiveness of company’s quality management system.

PROFESSIONAL EXPERIENCE

  • International Technidyne Corporation, Director, Manufacturing Engineering (Edison, NJ) – 7/09 to Present
  • Power Medical Interventions, Inc., Sr. Director, Product Development (Langhorne, PA) – 12/04 to 4/09
  • Princeton Optronics Inc., Staff Engineer (Princeton, NJ) – 11/01 to 12/04
  • JDS Uniphase Corp., Manufacturing Engineer (Princeton, NJ) – 12/99 to 11/01
  • Tyco International Ltd., Mechanical Engineer (Norristown, PA) – 10/92 to 12/99

EDUCATION

  • Master of Science, Electrical Engineering, Penn State University, Great Valley, PA – 08/04
  • Master of Science, Mechanical Engineering, University of Oklahoma, Norman, OK – 05/92
  • Bachelor of Science, Aerospace Manufacturing Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China – 05/86

TRAINING

  • Quality Management System, ITC,
  • Quality Policy, ITC
  • ISO 13485, ITC
  • Good Manufacturing Practices, ITC
  • Good Documentation Practices, ITC
  • Nonconformance Procedure, ITC
  • Corrective and Preventive Action (CAPA) Process, ITC
  • Preparation, Control and Distribution of Controlled Documents, ITC
  • Permanent & Temporary Engineering Change, ITC
  • Process Validation
  • Supplier Quality System Assessment
  • Failure Modes, Effects & Critically Analysis (FMECA) Procedure, ITC
  • Risk Management Procedure, ITC
  • Internal Quality Audit Process, ITC
  • Complaint Handling Procedure, ITC
  • Investigation and Root Cause Analysis Process, ITC
  • Software Validation, ITC
  • Test Method Validation, ITC
  • Production and Process Control, ITC
  • Statistical Techniques, ITC
  • Product Recalls, Corrections or Removals, ITC
  • Design Controls, ITC
  • Preventive Maintenance, ITC
  • Training Process, ITC
  • Medical Device Design, FOI, 04/13
  • Lean Six Sigma Green belt, ASQ, 12/13
  • Document and Data Control, PMI
  • Design Control, PMI
  • Management Review, PMI
  • Internal Audit, PMI
  • Process Validation, PMI
  • Management of Customer Complaints, PMI
  • Biohazard Control Plan, PMI
  • Monitoring and Trending, PMI
  • Statistical Control, PMI
  • Identification Traceability, PMI
  • Medical Device Reporting, PMI
  • Technical Files, PMI
  • Software Development Standards, PMI
  • Post Market Surveillance, PMI
  • Product Recall, PMI
  • Quality System, PMI
  • Incoming Inspection, PMI
  • Strategic & Disruptive Innovation, HSM, 06/08

AWARDS:

  • THORATEC Pinnacle Award for excellence in customer and quality focus and leadership in 2010