Notable Project Accomplishments:• Successfully setup production line in a new-to-business Contract Manufacturer (CM) in China under tight Covid-19 restrictions in 2022.• Created Dyson first ISO13485 Quality management System (QMS) related to manufacturing• Successfully launched hair care projects.• Improved new filter supplier’s yield and production for peak season using Lean Six Sigma methodology.Job Details:• Lead the manufacturing process development of complex new category processes in a structured way that complies with necessary regulatory requirements and maintain documentation evidence of each section, achieving required milestone maturity at a given cost and timeline.• Play an active part to provide leadership, especially in ISO13485 as subject matter expert.• Lead the team in establishing process validation protocols (IQ/OQ/PQ), work with supplier and CM to commission, and validate the production equipment.• Develop experiment plans to define process margins using DOE.• Proactively identifying and leading technical risks discussion within projects and influencing design teams in their resolution, often taking the lead in the design and testing of the engineering solution, using tools like PFMEA, NUDD, DFMA and DFX.• Develop a culture of Good Manufacturing Engineering practice, continuous improvement.• Propose production assembly flow, line layout, equipment list, CAPEX budget, production takt time with MTM.• Lead the team in working with suppliers to conduct Equipment FMEA to deliver solutions.• Set-up process monitoring in line with quality expectations, using key tools like SPC, MES.• Maintain communication and status update to stakeholders.• Problem solving and root cause analysis of product failures using Lean Six Sigma, 8D, SPC.• Process optimization.• Contribute manufacturing requirements in RFQ.

Job Details:• Manage projects, products transfer, leading and completing Customer's PPAP requirements, testing and validations for medical device manufacturing.• Lead a team of functional project members.• Create yearly budget and training plan within department.• First point of contact for close communication with customer.Notable Project Accomplishments:New Medical Device Development• Successfully produce, met PPAP requirements, testing for medical device within tight timeline and product improvement during verification and validation• Completed 5 different models over the yearsLaser Marking Implementation• Research, procure and setup a in-house laser marking station for product• Create all new programs, fixtures, work instructions and training for personals• Test and laser mark on a variety of materials and shape• Raise and get customer approval for process site change, including necessary validations and part qualification• Successful implementation which resulted return in investment within a year and save a noticeable yearly running expenseUnique device identification (UDI) for Medical Device• Conduct impact assessment and update all existing documents, process and products to UDI specification and qualified them with customerProcess improvement• Introduced similar barcode verification (using vision camera and barcode scanner)and label printing program with additional RFID scanning and program onto new projectMedical Device Automated Manufacturing Machine Transfer• Led a team of Engineers to bring in, set up and manufacture.

Projects involved:Vessel Satellite Communications Project(Initial Manufacturing), Wind Energy Generator and controller, Installation of Wind Generator on boats,Medical Device Production.Job details:• Lead production and assembly by • Develop manufacturing processes for new products, equipment, and set-up • Create equipment Installation, Operational and Performance Qualification • Generate technical documents (BOM, WI, Route card, pFMEA, Control Plan etc) • Develop and execute test plan for product • Train operators, technicians on relevant documentation • Apply knowledge of Lean Manufacturing, balancing and improving cycle time with focus on good quality and yield • Incorporate Good Manufacturing Practice • Design fixture, jig for production, packaging and quality use • Develop new design and improvement of product with customer • Engage in close communication with customer in Europe, USA • Lead and drive engineering changes with justification and impact assessment • Involve in NCR, MRB for quality issue • Participle and lead in Root Cause Analysis, Corrective and Preventive Actions • Work with different department and functional teams like Quality, Production, Planning, Sales, Logistics and Operations • Lead a team of operators and technicians • Remote off site, including overseas, for ship vessel installation and troubleshootingNotable accomplishments:• Create new and transfer existing manufacturing details to ERP software( MS NAV)• Part of team to install a first boat with wind and solar generator overseas• Introduced and set up Laser Weld Process, setup, test and operations. • Learning from scratch, applying and transferring knowledge of laser weld to operations • Improve first pass yield from 60% to 90% and reduce final scrap to <5%• Create and implemented a series of process and program concept for barcode verification and label printing, to reduce manual error and improve cycle time

Airport Operations Terminal 3