Engineer Quality Assurance

* ***** ****

Dear Mr(s). Human Resources / Hiring Manager

I am eager to enhance my personal and professional development by pursuing

your open position as a Post Market Investigator III.

I have worked for Medtronic for several years, in different positions and

departments. My skills and experiences will provide you with the leadership

and knowledge that you need from a person in this position.

I worked as a Program Manager at Medtronic Cardiovascular in Santa Rosa,

California. I was core team leader for a variety of projects, being my main

focus the next product launch in the US market for the Thoracic Aorta

Aneurism market, which was successfully approved by FDA prior to my

departure.

My responsibilities have included leadership and overall responsible for

project planning and execution; which included a cross functional team

located in multiple sites (Santa Rosa, CA / Tijuana, MX /Galway, IR).

Provide communication to all stakeholders and motivate and direct the core

team and extended team during the course of the project providing a

successful execution according with project contract.

I would like to continue my professional development pursuing your open

position of Post Market Investigator III and utilize my experience and

technical background as a Quality/Reliability Engineer in a fast paced

regulated environment, as well as my bilingual skills.

I am committed to providing the highest quality output in order to exceed

customer expectations, applying my solid leadership and interpersonal

skills, innovation, strong problem solving and communication in my

professional and academic experiences.

Thank you for your consideration.

Sincerely,

Jenny Neumann

Summary

Experience engineer in challenging positions in regulated industries such

as medical device and petroleum; focused on Project Management and Quality

Assurance. Product development and submission experience includes: PMA

Supplements, amendments and annual reports. IDE, 510(K)s and European

Technical Files. FDA inspections and regulatory audits by notified body.

Process development PC, IQ, OQ, PQ.

Professional Experience

Medtronic Cardiovascular- Endovascular Innovations

May 2005 - Oct 2009

Assoc. Program Manager (Department: Research and Development)

Dec 2008 - Oct 2009

. Core Team Leader, responsible for planning and execution of product

development projects from concept development to market introduction,

with a reduction of 3mo within the timeline FDA granted.

. Developed Product Launch Plan for next product introduction, including

revenue projections, product pricing strategy and strategy for product

introduction.

. Leadership and coordination of 2 Supplements to save $2.8M in inventory

that granted me recognition by Cardiovascular Sr. Management and a

Personal Performance Excellence Award.

. Responsible for project budget, resources and execution. Present project

progress to Product Review Committee and drive the decision making

process to maintain execution.

. Project Leader of sustaining engineering projects in Santa Rosa of the

Medtronic Endovascular Product (between Galway, Ireland, Santa Rosa, CA,

Tijuana, Mexico and Other sites)

. Continuous projects updates to Sr. Management. (Phase Reviews and

Exceptional reviews)

Design Assurance (Reliability) Engineer (Department: Quality Assurance)

July 2007 - Dec 2008

. Quality Core Team member for production lines being transferred to

Medtronic Galway.

. Quality Core Team member of Talent Gorilla projects, key contributor

during FDA Interactive Review Process as a result both products (TAA and

AAA) were approved by FDA in 31 days, and market launch 1.5 quarters in

advance.

. Responsible of supporting Design Verification testing and leading Shelf

Life testing planning, managing over 800 products and 3 sites (Galway, IR-

Santa Rosa, CA and Tijuana, MX).

. Leader of project risk management activities including PHA, RMR, DFMECA

and PFMECA.

. Leader of yearly Post Market Safety Reports (PMSR) for Reliant, Occluder

and Talent product lines.

. Leader of root cause investigation to address test failures and product

quality issues saving ~1.5M of product in inventory.

. Responsible for developing and validating clinically relevant test

methods (15 Test method to support Talent TAA/AAA and Reliant)

. Perform supplier qualification and vendor audits for new components.

. Train engineers and technicians in Statistical techniques.

Associate Quality Engineer (Department: Quality Assurance)

May 2005 - July 2007

. Provide technical assistance for product transfer, process qualification

and validation in a fast paced manufacturing enviroment.

. Leader of CAPA process and audit findings plan of actions and closure.

. Support complaints investigation and health hazard analysis for products

to determine field actions including evaluation of returned devices, root

cause investigation, corrective and preventative actions in response to

field complaints.

. Qualification of new components and raw materials.

. QE support to 5 product lines; including Non-conforming material reports,

SPC, on-line inspections and testing. Maintaining continuous operation of

the line to ensure that production levels were met.

. QE support during SAP implementation in the Endovascular Business.

Puerto La Cruz Refinery (PDVSA). Venezuela

Nov 2002 - June 2004

Strategic Reserve of Personnel. (Trainee Engineer, Department: Process,

Area: Industrial Services)

Responsible of supervision of effluent process plant. Data analysis and

process parameter monitoring through Statistical Process Control and

application of various quality tools.

Provide quality verification of the samples and correct analysis operation

conditions and verify waste streamlines.

. Providing process yield and loss, process improvements and develop/

participation in new project in environmental field.

El Palito Refinery (PDVSA). Venezuela

Oct 2001 - July 2002

Internship (Department: Security, Hygiene and Environment)

. Develop an effective system design of a biological treatment for final

disposition of oily sludge to meet EPA requirements for safe disposition.

. Defining and executing multiple experiments to adapt the design

parameters, generating kinetic constant for software simulation of the

designed system. Final design was able to reduce 94.3% of HC

concentration in the oily sludge

. Reduced the investment up to 65% and processing time up to 30%.

Achievements

> "Medtronic Start of Excellence Award", October 2009

> "Certificate of Appreciation". October 2009

> "Individual Performance Program Award". April 2009

> "Excellence in Partnership Recognition". June 2007

> "Quality Employee of the Quarter" 3rd Quarter of FY06.

> Honored by University of Carabobo with 4/4 points. (Internship)

> Published in the Iberoamerican Congress of Sanitary and

Environmental Engineering in Cancun - Mexico in October 2002.

Education and Certifications

B.S. CHEMICAL ENGINEER, University of Carabobo. Venezuela.

July 2002

Certified Quality Engineer (CQE) - American Society of Quality (ASQ)

2007

Professional Skills

Skill set includes managed global programs, project management, six sigma,

lean manufacturing, statistical analyses (MINITAB), continuous improvement

methods, CAPA, proficient in Microsoft, CAT, compliance audits and ability

to handle several projects simultaneously and to thrive under pressure and

motivate others. Bilingual Spanish-English.

Other Courses:

2009 Project Management - Worcester Polytechnic Institute

2008 Co-Facilitator of Statistics for Engineer - Medtronic

2008 Risk Management (ISO 13485) - Medtronic

2007 Green Belt Lean Sigma Training - Medtronic

2007 cGMP and GLP for Regulated Environments - Medtronic

2006 Process Validation - Medtronic

2006 Design of Experiments (DOE) - Medtronic

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