David Yip

Background

About David Yip

I am a medical device engineering manager specializing in Laboratory Management, equipment, test method design/validation, and Design Verification project management. Over the past 7 years working with Kinetic Concepts Inc (KCI) which was recently purchased by 3M, I have had the opportunity to work with large cross-functional and international teams allowing me to cultivate and develop skills that would be useful and beneficial for such a position. Those skills include: • Assisting with the design, development, and testing of medical devices for both new and sustaining products tracking metrics to measure improvement initiatives to meet system & operational requirements. • Created value stream maps to analyze the current state and design a future state for various lab processes to perform gap analyses and improve work function and value. • Lead projects with cross-functional teams to promote company growth, operational efficiencies, and the organizational culture of continuous quality improvement. This includes working with other sites internationally to streamline, standardize, and align processes. • Consult on project teams as a test method validation DV expert assisting in continued improvements, and the lead for the Design Verification and Stability Team. • Performs continued internal quality assessment audits to meet requirements, conduct quality assessments for other departments, and support multiple routine auditing activities from regulatory bodies such as FDA and ISO. • Lead the creation and management of testing laboratories in the US, India, and the UK. This includes standardization of the test method development, improving operations, management and tracking of equipment (PM and calibrations), and the direct management of the test technician teams (as many as 15 technicians) on hardware and software. • Directly supervise the training and continued development of cross-functional departmental engineers and technicians • Received training in operational improvements through the use of tools and programs such as 5S+safety (6S), Total Quality Management (TQM), and K-J Method to reduce the number of defects and to improve processes by reducing waste.