James (Chieh-en) Wu

Seattle, WA acuf0p@r.postjobfree.com (765) 430 – 3658 www.linkedin.com/in/jameschiehenwu

Personal Profile

Enjoy solving problems with analytical skills, and eager to overcome any technical challenges

Medical Device (Implants, Surgical instruments) experience

Experience with Design Controls that are compliant with FDA and ISO standards

Familiar with DCTM, dFMEA, pFMEA, design V&V using Engineering Analysis and Clinical Performance Reports

Programming Skills: MATLAB, C, VBScript, Shell, ActionScript 3.0, Quick Test Professional

Proficient with Microsoft office: Word, Excel, Powerpoint, Outlook

Education

Purdue University, West Lafayette, IN December, 2013

Bachelor of Science in Biomedical Engineering (Minor: Electrical Engineering) GPA: 3.21/4.00

Engineering Experience

Development Engineer, QSR project Team Lead, Zimmer Biomet Holdings Inc. March 2014 – June 2015

Created and updated design verification documents such as tolerance stack-up analysis, engineering rationale memos, Functional Relationship Analysis, Clinical Performance Summary, and Similar Device Analysis.

Led a multi-disciplinary team to remediate Design History Files of various medical implants and instruments and align them with the FDA 21 CFR 820 and ISO 13485 compliant QSR.

Reviewed and updated all design control documents within the DHF such as Design Process Change Log, DCTM, dFMEA, pFMEA, as well as verification and validation evidences to ensure they meet the quality standards.

Held design reviews to discuss gaps and gap resolutions within the DHF.

Biomedical Engineer, Gastroparesis Auto-Stimulator Project, Senior Design August 2013 – Dec 2013

Developed circuit to amplify and filter signals from electrogastrogram to detect stomach muscle activity.

Built circuit for RF transmission to integrate external sensing component and internal implantable component.

Project Leader, Adaptive Sail Boat Project, EPICS Camp Riley Team July 2013 – August 2013

Constructed prototypes of motorized rudder and adaptive control, and interacted with the stakeholders frequently for feedback.

Conceptually designed an adaptive sailboat that allows people with disabilities to control the direction of the sailboat.

Clinical Systems Engineer Co-op, Remote Care System Team, St. Jude Medical January 2012 – July 2012

Wrote and executed verification and validation test scenarios and test procedures to ensure the remote care system meets the system requirements, functional specifications, and customer workflows.

Developed and implemented process improvements using six sigma principles to improve the productivity and efficiency of the team and reduce wastes in the workflow.

Managed System Requirement Validation with DOORS.

Designed and performed reliability tests on current remote care system to detect potential field issues.

Engineer, Hydraulic Ramp Pump Project, EPICS Water Resource Management Team August 2011 – December 2011

Created parts, assemblies and drawings using Solidworks.

Built prototype and preform testing to validate the design and to determine the limits of the design.

Engineer, Hand-eye Coordination Game Project, EPICS Saint Vincent Advance Team August 2010 – December 2010

Created a flash game using Adobe Flash CS5 in along with PlayStation3 Guitar Hero Drum set that measures reaction time.

Communicated with the project partner to determine the needs and constraints of the design.

Contact this candidate