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Engineer Quality

Location:
Round Rock, TX
Posted:
May 26, 2016

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Resume:

Sue Mao

*** **** ****** **** ***. 973-***-****

Round Rock, TX 78681 acuyqp@r.postjobfree.com

SUMMARY

In depth experience of System Engineering & Technical Program Management with proven experience including roles as team leader of complex program in cross functional design, test, manufacturing, customer service, marketing teams with international environment.

Principal System Engineer and Expertise in complex system design, manufacturing process and quality in all stages of program development and system integration from product concept, marketing definition and customer requirement to system requirements, regulations & specs though develop & technology implementation, verification for product launch in global market Asia, Europe, USA. And maintenance products quality solving field issues in complex & cross functional area of Opto-Mechanical-Electrical Hardware, Software of the controllers; and the quality issues in manufacturing, internal, external partners & supply chain. With team successfully delivered large cross functional platform products to global market, achieved targets in Quality, Cost, Delivery schedule (QCD)

Total Process in new product life cycle System Development & Integration for product QCD and

Improvements. Preventative Lean Six Sigma process excellence; Process Optimization

Multifunctional System Integration Team Management; Problem & Change Management; Cost Down

Broad technical skills & knowledge in system engineering from the experience at industries & universities

Technical Expert in Opto-Mech-Elec-SW System for new program development, design, test & issue solving

Experience in international environment, Asia, Europe & USA

PROFESSIONAL EXPERIENCE

Siemens, Health Care & Diagnostics 2012-Dec 2015

System Engineering Lead, Risk Manager, Staff Engineer

Key word

System Engineering Functional Leader, for medical device development & delivery meeting the requirements of quality, cost, schedule, FDA & ISO regulation, risk management & reliability.

Lead system engineering team in both of process planning & technology development providing

direction & evaluation. Develop system level requirements, subsystem design specs & phase gate

criteria. Allocation reliability specs. Lead Risk Management & hands on hazard/harm analysis,

risk assessment& risk mitigations / corrective methods of HW, SW in design input & output;

design control & change management; Master risk coach for the program; expert of FTA & FMEA.

Closely work with regularly & medical affairs. Design for Six Sigma expert & coach for performance optimization both in test & simulation methods. Run weekly system engineering & risk management

team meetings, providing direction for the safety of patient, operator & environment.

Modelling & Simulation to pre detect system performance, interface with Corp research for Imaging Process. Drive Opto-Mechnical-Electrical system design review & verification test plan, fixture plan. Define system requirements for SW & track schedule, performance.

Drive cross functional feature teams for system integration plan, test for Opti-Mech-Electrical HW

with Software; problem management, issue solving & root cause analysis. Interface with Project Management team to meet schedule; Manufacturing team for vendor, quality &cost.

Also interface with User Experience & Industry Design, Marketing & Service teams.

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Xerox Corp, Webster NY, USA 1994-2012

Principal Engineer, Technical Program Manager (TPM) 2000-2012

TPM & Principal Engineer, Technical Leader for new product system integration for product development team of Mechanical, Electronics, SW controller design, testing, supply chain, manufacturing engineers for the delivery of color products across multiple platforms. Professional strengths are product technical management, TTM process, system development & integration; Imaging Quality, Motion Quality & Control, Heat Transfer, DfSS, ISO, EHS, regulatory compliance, vendor & quality assurance. Established new products planning for quality specifications, deliverable criteria, quality improvement initiatives; new quality metrics & quality audits system, process. Team leader of Imaging & Xerographic system, cross functional teams for PFMEA (pre failure mode analysis) process, consolidated potential failure modes; decided critical parameters with CPK requirement to be audit in high volume production line thus saving cost for millions.

System Engineering Team leader of PMC for quality problem identification, action plan & track the problem solving. Quick problem solutions, trouble shooting for HW & consumers, SW issues from partners, design, manufacturing, test & field. Problem & Change management, assign severity rankings, risk priority number. Assured data availability & integrity for those system quality related data tracked & statistically analysed to completion.

Follow Lean process, with team analysed the filed data for returned toner cartridges, used Lean Six Sigma for toner quality control, improved process & usage, thus change SW resulting in cost saving of millions.

Simultaneously work on & deliver multiple projects, tasks successfully. Delivered multiple new cross functional products into global market being international leaders with 5 quality stars from BLI.

Mechanical Design Manager 1994-2000

Hands on design engineer for metal & plastics parts, electronics package in AutoCAD. Manager for mechanical engineering team including 20 members of engineers, designers & technicians. Responsible for quality, design & quality inspection test procedures, vendor & supply quality; reliability data statistics analysis of mechanical & Consumers. All designs were verified, delivered on time and on budget.

EHS, System Motion Quality, Heat Transfer, Lab View & Imaging Quality, statistics analysis expires achieved driver system motion quality solving system vibration issue.

Coordinated & interacts with 2nd & 3rd party auditors in regards to audit plan for quality define critical item CPK requirement for manufacturing line; implementation & results.

Hands on AutoCAD with Finite & Boundary Element Analysis for optimization design for the thermal solutions to reduce the cost & meet quality requirement.

Also led 5 system engineers responsible for integration mechanical design into system; product development internal system support & external system support for marketing, customer services, and manufacturing as well international operation companies.

Established a product test procedure for HW, SW quality knowledge base, customer documents, service documents, service criteria; resulted the products successful.

Milton Roy Medical Instruments, Rochester NY, USA 1989-1992

Senior Mechanical Design Engineer

Mechanical design for new products; optical & electronics component assembly; plastic

parts design system architecture & analysis; DFMA, manufacturing tooling preparation,

precision grating and application in medical devices.

Rochester Institute of Technology, Rochester NY, USA 1987-1991

Visiting & Exchange Professor; Adjunct Professor (1994~present)

Mechanical Heat Transfer test lab for teaching & Robotics Design lab for testing &

coaching students. Teaching undergraduate courses:

Teaching undergraduate courses Machine Design, Stress & Material,

Heat Transfer, AutoCAD & graduate courses Mechanical Optimization Design

EDUCATION

Master & Bachelor Mechanical Engineering Jiao Tong University, Shanghai China

PH. D study Mechanical Engineering Clarkson University, Potsdam NY USA

(Candidate as courses & qualified exam passed, thesis to be passed)

MAJOR PUBLICATIONS & Articles

Mechanical Optimization Design Graduate Text Book

Design for Manufacturing Undergraduate Text Book

Acoustic Design Using Boundary Element Method Acoustic Technology

Optimization for Zero Position Grating Optical Technology

LANGUAGE CAPIBILITY

English, Chinese (multiple dialogues) in Speaking, Writing

Russian & Japanese

Others

USA citizen

Member of ASME; DFMA

Member of RIT (Rochester Institute of Technology) Model Rail road Traffic Club, Robotics Club

Certification of DfSS ASI-CG Consulting LLC 2013

Certification of Master Coach, Risk Management & Analysis for Medical Device, Siemens 2013

Certification of Labview, National instruments 2013

Certification of quality management, (Signed by senior VP) Siemens 2013

Certification of Green Belt Xerox 2010; PMP Xerox 2006

Professional Woman Society; Rochester Opera Eastman School.

Skills: Microsoft tools, SAP, Teamcenter, TFS, Minitab, Matlab, ProE, AutoCAD, FEA



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