Lu Chen Email & Phone Number

• A company provides innovative design and development services for optical-based IVD devices and microfluidic-based POC assay technologies, along with support for regulatory compliance and clinical trial management.
• Create roadmap and define product specification to target market needs.
• Improve strategic planning and communication through creating clear, practical plans and timelines that enable teams to make well informed decisions. Implement a robust project management framework throughout the.
• Evaluate project needs and prioritize tasks. Oversee entire program lifecycle, from planning to execution, ensuring projects are delivered on time, within scope, budget and to quality standards.
• Lead product development, collaborate with cross-functional team of 10-12 members, including engineering, design, manufacturing and regulatory affairs, to integrate and develop the product. Manage interdependencies.
• Identify, assess, and manage project risks. Proactively address issues to ensure timely resolution and on time project delivery.

Toronto, Canada Area

• Developed an integrated point-of-care testing and monitoring system based on immunofluorescence optical detection to address the current clinical challenges in global health.
• Implemented design control processes during development.
• Experienced in study design, protocol writing, execution, data analysis and results interpretation.
• Skilled in requirements generation, risk analysis, DFMEA, traceability matrix etc., all in compliance with regulatory requirements.
• Went from idea to concept to prototype to pass internal testing using clinical samples successfully. The system combines patient identification, blood testing, communication, and external quality management protocol.
• Led a multidisciplinary team to develop both the instrument and disposable microfluidic testing cartridge. The complete IVD assay development has been conducted.

• Designed, fabricated and tested capillary microfluidic devices for fluidic flow control, particle enumeration, and reagent mixing.
• Developed lyophilized reagents for use on the microfluidic chip.
• Designed and constructed optical system for a miniaturized fluorescence microscope.
• Built portable cell analyzer prototypes.
• Investigated the performance of portable cell analyzer prototype using beads, Immunotrols, and human blood samples.
• Developed and tested innovative simultaneous multicolor detection capability for portable cell analyzer prototype.

Ph.D., Bioanalytical Chemistry

M. Sc., Surface Chemistry

B. Sc., Chemistry