Andrew C. Ku

*** ******* ****** *****, *** ****

Universal City, TX 78148

937-***-**** ▪ p7ktew@r.postjobfree.com

PROFESSIONAL SUMMARY

Proven Project Lead / Manufacturing Engineer with over 10 years experience in R&D, operation and sustain Manufacturing environment, focused on process improvement and design projects within the medical device industry. Strong leadership and self-motivational qualities, problem solving, analytical skills and interpersonal skills, with the ability to communicate comfortably within all levels of healthcare sectors as well as engineers and technicians. Fluent in both Chinese and English.

PROFESSIONAL EXPERIENCE

Kinetic Concepts, Inc., San Antonio, TX 2/2009 – 1/2010

Project Lead / Manufacturing Engineer

· Project lead on validating design upgrades to manufacturer’s replacement product. Prepare test protocols, analyze data and generate test reports. Also, manage engineering change orders, which include update drawings, revise work instruction and QC check list.

· Manage a multi-millions dollar UL 60601-conversion project. Supervising 2 engineering consultant firms, project scheduling, engineering migration and implementation, cost analysis, risk assessment. Also, prepare all the design control and V&V documentation for product launch.

R.H. Burton Company, Grove City, OH 7/1999 - 10/2008

Product Design Engineer

· Implement Six Sigma DMAIC methodology on several ophthalmic device projects, to improve lead times and reduce engineering rework by 30%, reduce $50,000 on annual warranty costs, 65% improvement in product quality and manufacturability in two years, as reported per the company’s annual report.

· Increase 36% sales volume by conducting and providing expert contribution to qualify instruments built for UL60601 and ISO13485 medical standard.

· Work with doctors and opticians in conducting brainstorming sessions to evaluate eye examination devices and implement value stream management into their business.

· Construct prototypes for field studies.

· Perform market research, evaluate technique and research ophthalmic devices for design optimization.

YOTEC, Inc, South Charleston, OH 8/1996 – 7/1999

Manufacturing Engineer Technician

· Increase annual production 10% via standardizing operation sequences, workplace layout, machines, tooling and processes required.

· Provide technical floor support to engineer technicians.

· Contribute as part of an ISO9001 team, responsible for writing Standard Operation Procedures (SOP) for assembly lines.

EDUCATION

· Wright State University, Dayton, OH, B.S. Biomedical Engineering

PROFESSIONAL AWARDS / CERTIFICATIONS

· Reward Certificate, Six Sigma / Green Belt and Lean Manufacturing

· Certificate, Design Validation, Verification and Risk Analysis for Medical Device

· Certificate, PMP, Risk Management, per ISO 14971:2007

MEMBERSHIPS

· International Quality Federation (IQF)

CORE COMPETENCIES

Design Tools and Software:

· Solidworks 2007

· MS Office, Visio, Project, Sharepoint

· SmarTeam, SmartSolve

· Oracle

· Six Sigma (e.g. FMECA, Pareto Chart, VOC, ROI, OEE, Ishikawa Diagrams, etc)

· Lean Manufacturing and Value Stream Management techniques

Regulatory Requirements, including:

· UL60601-1, IEC60601-1-2, -2-35, -2-38

· ISO13485: 2003, ISO14971: 2007

· FDA’s QSR

· CE Marking

Contact this candidate