Project Product Development

EVA C. NAUGLE

Phone: 408-***-**** email:*********@*****.***

SUMMARY

Extensive product development and launch experience, including PMA, 510(k), Class III for single use, implant, and capital equipment devices.

Experience in managing quality compliance program and implementing Quality Management System projects.

Successful PMO implementation for organizations.

PMP certified since 2005, PMP# 241508

EXPERIENCE

INCUMEDX INC. Fremont, CA Current

Program Management Consultant

Implement Quality Management System and lead successful ISO 13485 certification and annual surveillance audits as the Management Rep.

Identify and execute opportunities for continual process improvement in product development processes.

Control and communicate project/program level risks, issue management, and project quality.

Direct and coordinate program activities (schedule adherence, program budget, plan tracking, milestones, scope changes, design-to-cost objectives, plan updates, and weekly team meetings.)

Lead customer interactions for individual programs, with a strong focus on customer expectation management.

Develop and maintain program plans and communicate program status to customer(s) and internal teams.

Guide successful completion of projects though collaboration with R&D, outside consultants and suppliers, and customers.

Lead organization PPM (Portfolio Program Management) implementation initiative.

BOSTON SCIENTIFIC, CORP. San Jose, CA 12 ‘07 – 3 ‘14

Program Manager

Managed $16M PMA Class III devices (Open Irrigated RF Ablation System) New Product Development program through accelerated Design Control and successfully achieved submission deliverables.

Managed Global Labeling Compliance program including MBI, KEMA labeling conversion, MDD, and EN/ISO labeling standards projects.

oWorked with multi-site teams for the implementation of labeling requirements.

oConducted business impact analysis and defined project scope for execution.

Managed re-certification project for Imaging Catheters.

oWorked with Regulatory, Design Quality Assurance, R&D, Manufacturing Engineering team to determine re-certification strategy, requirements, and execution plan to ensure no commercial impacts to existing product lines.

oSuccessfully achieved CE marking re-certification goals

Managed RF Generator Design Change Project.

oCollaborated with R&D, Marketing, Sales, Service Organization, and alliance manufacturing partner to determine product improvement requirements.

oResponsible for project schedule, budget, and communication to stakeholders.

oConducted Design Control Design Reviews and completed design transfer to Contract Manufacturer

VNUS MEDICAL INC. San Jose, CA 07 ‘07 – 02 ‘08

Program Management Contractor

Managed product development system project including RF Catheter, Generator, and Software Release.

Mentored 4 project managers in establishing best practices and methodologies.

CONOR MEDSYSTEMS, CORP. Menlo Park, CA 03 ‘07 – 07 ‘07

Program Manager

Responsible for US drug eluting stents launch projects: new facility validation, FDA Pre-Market approval inspection, process validation, and design/analytical method transfer.

Facilitated for $25M construction project.

Led project management initiatives in developing strategies, action plans, and training requirements.

BOSTON SCIENTIFIC CORP. Fremont, CA 12 ‘00 – 3 ‘07

Project Management, 2005 - 2007

Managed Intravascular Ultrasound (IVUS) Imaging System and DICOM software projects.

Achieved franchise product launch goals by executing project on-time and within budget.

Conducted up-front project scope requirements and risk analysis with global marketing and development teams to implement customer feedback.

Collaborated with global marketing team, Service, and Operations to determine product life cycle requirements and customer support strategy.

Cultivated an empowered team with strong emphasis on documentation, code reviews, and comprehensive unit and system level testing.

Project Management Office, 2003 - 2005

Managed monthly Project Investment Board (PIB) business review meetings.

Assisted in the establishment of Project Management Office for the Imaging franchise to drive project execution excellence.

Facilitated project kickoff meetings and team building activities.

Assisted project leaders in managing project priorities.

Supported project leaders on project planning, monitoring, and controlling.

Coordinated specific project workshop to meet project objective, key deliverables, and milestones.

Global Supply Chain, 2000 - 2003

Executed 5 product launches by working with the product development teams, global marketing team, and operation.

Managed $7M worldwide monthly inventory of medical devices, capital equipment, and service parts for 3 franchises.

Achieved 98% service level by setting priorities, allocating resources, and measuring franchise performance.

Conducted and facilitated monthly Marketing, Manufacturing, Sales and Operating Planning meetings.

Achieved 20% worldwide finished good inventory reduction by implementing JIT.

EDUCATION

Keller Graduate School of Management

MPA with Healthcare System Concentration

MBA

DeVry University

BSTM with Project Management Concentration

Skills and Qualifications

Read, write in Chinese and speak Mandarin & Taiwanese

Strong presentation and written communication skills

CAPA Initiator/Evaluator, Investigator, Resolution Planner

Software Skills: Microsoft Office (Word, Excel, PowerPoint, Visio), SAP, ReqPro,

ClearQuest, Arena PLM, PDM

Proficient with ISO 13485, ISO 14971, and ISO 10993, and CFR 820 requirements

for medical devices

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