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Heather H

Accomplished New Product Development & Quality Assurance Manager

Occupation:

Product Design Engineer

Location:

Hollywood, FL

Education Level:

Master

Will Relocate:

No

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� Accomplished, self-starting New Product Development and Quality Assurance engineering manager � Over 10 years of experience in medical device development � Hands-on experience leading product development cycle from concept selection to commercialization in both New Product Development and Quality Assurance management roles, including voice of customer activities, concept selection, design characterization, verification and validation, and commercialization. � Coordinate projects over multiple locations, including site transfers. � Known to deliver project commitments early and have executed multiple projects simultaneously, providing direction to separate project teams from concept to commercialization. � Extensive knowledge of design control and QSR requirements and excellent communication, technical writing, and analytical skills. � Exhibit collaborative skills within a team environment and with customers. � Effectively develop personnel by establishing clear goals and objectives for direct reports with regular communication and an open door policy.

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COMPANY POSITION HELD DATES WORKED

(Confidential) (Confidential) 5/2005 - Present
Cordis Corporation, A Johnson & Johnson Company (Confidential) 7/1997 - 5/2005
IEP Group, Inc (Confidential) 5/1994 - 8/1994
General Motors Reliability & Test Department, (Confidential) 5/1993 - 8/1993
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SCHOOL MAJOR YEAR DEGREE

Florida International University Engineering Management 2001 Master Degree
Dartmouth College Biomaterials Engineering 1997 Master Degree
Duke University Biomedical Engineering 1995 Bachelor Degree
Duke University Mechanical Engineering & Materials Science 1995 Bachelor Degree
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Highlights:

Companies I like:

Johnson & Johnson, General Electric, Kimberly Clark

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Accomplished, self-starting New Product Development (NPD) and Quality Assurance (QA) engineering manager with over 10 years experience in medical device development. Proven track record leading product development cycle from concept to commercialization. Ability to deliver and manage projects simultaneously, providing direction to separate project teams in multiple locations. Subject matter expert in design control documentation with extensive knowledge of Quality System Regulation (QSR) requirements. Certified American Society for Quality Manager (CQMa) and Six Sigma Green Belt. Excellent communication, technical writing, and analytical skills. Highly collaborative team player that effectively develops personnel by establishing clear goals and objectives with regular communication and an open door policy.
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