Manager Medical

Dear Representative:

Please consider my application for Director of Reliability Engineering with

the company you represent. I am currently a Staff Reliability Engineering

Manager at Siemens Medical DX with over thirteen years experience in

industry. Below are just some of my qualifications and experience:

. MBA

. Manager of Reliability and Risk Management for POC Division

. Implementing a New Risk Management Process for a Global Company

. Six Sigma Black Belt Training and certification

. Expert knowledge in Statistics, DOE, FEA, ALTA, FTA, FMEA, HAZOP, DFMEA

. Expert knowledge of HASS, HALT, DFR, DFM, ALTA, RGA and so on

. Have Implemented new Reliability Program from the Ground Up

. Manager of Conformity Assessment for Medical Devices (TUV, UL)

. Global and Multi-site procedure development and Implementation

. Experience with R&D and development of New Medical Products from Start

to Finish

. Experience hitting deadlines on time and under budget

. Budget Analysis and Planning

. Have published many internal Training Presentations and Procedures

. Advance Software Experience: Weibull, Pro-E, Minitab

Prior to Siemens, I worked for Bayer Diagnostics, Underwriters

Laboratories and Marquette Medical Systems. These positions required

skills in project management, cost analysis, international standards,

and regulatory compliance auditing. At Bayer Diagnostics, I became

proficient in product life cycle testing, reliability metrics, and

training fellow engineers on risk management topics.

I am a graduate of Marquette University with a Bachelor of Science degree

in Bioelectrical Engineering, and have an MBA from UOP. I have also

received extensive sales training, from developing plans to closing deals.

My success at selling to both external and internal customers, I attribute

to my passion, persistence, and presentation skills.

I love challenges, hard work, and projects that exceed normal limits. I am

looking for growth-oriented companies with amazing benefits that will help

me grow to my potential and vies versa.

Please review the enclosed resume for a complete description of my

qualifications and experience. I look forward to discussing career

opportunities with you in greater detail. Thank you for your kind

consideration.

P.S. I would love to return to the Northwest

Sincerely,

Justin Gagnon

Justin Gagnon

210 High Street, Abington, MA 02351

Cell: 360-***-****, Email: **********@*******.***

Employment History Education & Training

Staff Reliability Engineering Manager, MBA from UOP, 3.86 GPA

Siemens Healthcare DX, 10/09-present Comprehensive Six Sigma Black Belt

Manage reliability & technicians for POC Training, 2007

division Reliability Metrics, RGA, ALTA, BlockSim

Manage risk management for POC division & Weibull, Reliasoft Corp., Tuscon, AZ,

Manage Code Compliance for POC division 2005

Senior Reliability Engineering FRACAS Training, Reliasoft Corp.,

Supervisor, Siemens Medical DX, Tarrytown, NY, 2005

03/08-10/09 EIT Certified with Medical Safety

Senior Reliability Engineer, Siemens Standards, Underwriters Laboratories

Medical DX (Bayer Diagnostics), Norwood, (UL), Camas, WA, 2002

MA, 06/02-03/08 Interpersonal Communication Skills, UL,

Perform reliability allocation, life Camas, WA, 2000, ISO 9001 Trained auditor

cycle & reliability tests 2001

Train engineers in FTA, FMECA & FRACAS BSE, Bioelectrical Engineering, Marquette

Engineer, Underwriters Laboratories University, Milwaukee, WI, 1999

(UL), Camas, WA, 06/99-05/02 Sales Training & Motivational Speaking,

Manage safety certification & reverse Cutco, 1996

engineering projects. Sell certification Professional Recognition

services. Special Recognition Awards, Bayer

Manufacturing Engineer Intern, Marquette Diagnostics & Siemens, 2003, 2005, 2006,

Medical Systems, Milwaukee, WI, 2007 (x2), 2008, 2009, 2010

01/97-04/99 Engineering Fast Track, Bayer

Design, build and troubleshoot test Diagnostics, 2005

fixtures. Cutco Sales Award - Top 15 for

Write C/Visual C++ code for Aegis North-Pacific Division, Vector Marketing,

systems 1996

Research Assistant, Microwave Radiation, Cutco Presidents Club Award, Vector

Dr. Ishi, Marquette University, Marketing, 1996

10/95-08/97 Motivational Speaker at Cutco Regional

Salesman, Cutco Cutlery, 06/95-06/96 Sales Conference, San Francisco, CA, 1996

Great Midwest Conference All-Academic

Team, NCAA Division I Wrestling, 1995

Knowledge & Abilities Innovations @ Siemens Healthcare

Medical Equipment Testing Full conversion from UL to TUV in code

Reliability Analysis and Prediction compliance for all POC instruments @

All Reliability tools including Siemens, 2009

processes such as DFR, DFM, DFS, MIL Implement Design for Reliability (DFR)

Standards, HALT, HASS, ALTA, RGA, CAPA process for new medical instruments @

Stress Testing, Margin Testing and Siemens, 2008

Environmental Testing design and Implement Web-Enabled Risk Management

statistics involved. Process, Library and Database at Siemens,

Test fixture design, construction, 2008

implementation Use Accelerated RGT to meet time to

Project management, cost analysis, parts market, 2007

purchasing Create Ways to Save Money Using

Risk analysis, risk management, HAZOP, Reliability, 2006

FMEA, FTA, FMECA, Customize & install new FRACAS system,

Medical Safety Standards 2005

UL, IEC, FDA, CFR 820, 510K, ISO 14971, Develop Design for Reliability (DFR)

ISO 9001, ISO 13485, GMP, QSR, MDD, IVD, process for new medical instruments, 2005

MDR

Develop new Risk Management Process (RMP)

for

in-vitro diagnostic & early-stage

products, 2003

Publications & Training Materials Software Skills

Design for Reliability (DFR) process for Advanced Engineering Software

new products, 2008 Pro-E, Mechanical Drawing

Web-Enabled Risk Management Process Veribest, Electrical Schematics

Training, Siemens, 2008 Reliability tools: Weibull, ALTA, RGA,

Risk Management Process Seminar, Bayer, FRACAS, BlockSim, Reliasoft tools,

2005 Minitab

GSOP Risk Management & Global Quality, Programming - C++, Dynamic C, Visual C,

Bayer, 2005 Visual Basic

FMECA Seminar, Bayer, 2003-2005 Microsoft Office, Microsoft Project,

FTA Seminar, Bayer, 2003 Lotus Notes

MWI Risk Management Process, Bayer, 2003 Engineering Presentations

Asked to be a Guest Speaker at External

ISO 14971 Seminar, Bayer, 2002 Global Risk Management Conference, 2009

Risk Analysis articles, The Medical Web-Enabled Risk Management Tools and

Mark, UL, 2001 Files, 2008

Sales Skills Reliability Tools and Their Purpose,

Industrial & retail customer sales Bayer, 2006

Prospecting & business development Software Hazard Analysis, Bayer, 2006

Dynamic PowerPoint presentations Testing for Reliability, Bayer, 2005

Public speaking & communications Design For Reliability (DFR), Bayer, 2004

Technical trainer & seminar leader

Experienced web conference presenter Consolidating Data Islands, Bayer, 2003

Risk Management Process for New Products,

Bayer, 2002

510k Software Deliverables, Bayer, 2002

FDA 510k for Medical Equipment, Camas,

WA, 2001

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