Senior level experience in product lifecycle: personnel management (client & team), project planning, budgeting, requirements and analysis, design, risk management, coding / manufacturing, quality assurance, systems integration, validation & verification, release, support, maintenance, and auditing.

COMPANY	POSITION HELD	DATES WORKED
(Confidential)	(Confidential)	3/2002 - Present
MATCHLOGIC - EXCITE@HOME	(Confidential)	1/1998 - 9/2001

SCHOOL	MAJOR	YEAR	DEGREE
Univ. of Denver	CIS - Software Engineering	1994	Master Degree

Highlights:

Senior level experience in product lifecycle: personnel management, project planning, budgeting, requirements and analysis, design, risk management, coding / manufacturing, configuration management, quality assurance, systems integration, validation & verification, release, support, maintenance, and auditing.• Leadership experience running all aspects of a FDA’s 21 CFR Parts 11, 210, 211 and 820 systems development, remediation and validation programs / projects at departmental, site and enterprise level.• Certified Six Sigma Green Belt, Facilitator, and PMI’s Project Management Professional (PMP).• Established Program Management Office for prioritizing and managing cross-functional projects and resource allocation. Supervisor of project managers, validation engineers, and coordinators.• Expert knowledge of medical device and biotechnology workflow: design, supply chain, manufacturing, shop floor control, lot tracing, warehousing, and distribution.• Ten years supervisory experience with FDA regulated Medical Device and Biotechnology businesses.• Experience using Six Sigma, Lean, Risk Management, and Quality Management Systems to improve business and technical processes.• Implemented organizational and cultural change through the introduction of new global workflow / defect tracking system and associated supporting business and quality processes.• Excellent communication, presentation, writing, team leadership, and client relationship skills.

Companies I like:

Sun Microsystems, McKesson, IBM

P&L responsibilities
Presentation
Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts.
Technology Solutions
Sales Support
Software Implementation
Requirements Analysis & Specification
Leadership

• Director
• Manager

Experience using Six Sigma, Lean, Risk Management, and Quality Management Systems to improve business and technical processes.