1. Jessie Spencer-Cooke
6288 Hidden Meadow Ct.
San Jose, CA 95135
meddevicepm@gmail.com
408-274-3624
S K I L L S S U M M A R Y
Program management professional with extensive experience in medical device product development, project
management processes, global cross-functional team leadership, and portfolio management.
• Global program management of stage-gated medical products development – requirements definition through
launch.
• Design Control and Design History File control and adherence
• Regulatory (FDA, TUV, MHLW) requirements adherence and audit response
• Clinical, Quality Assurance and Risk Management requirements adherence
• Project Management Professional (PMP), certified by Project Management Institute (PMI)
• Project risk management, change management, issues management, communication, and reporting
• Project planning, scheduling, resource allocation, and budget
• Portfolio Management, strategic planning and budget management
• Extensive experience managing numerous large-scale projects simultaneously and coordinating efforts across
diverse groups and geographies
• Certified Kepner-Tregoe trainer – Potential Problem Analysis/Decision Analysis
• Global, cross-functional team leadership, decision making methodologies, and team meeting facilitation
P R O F E S S I O N A L E X P E R I E N C E
Boston Scientific Corporation, Electrophysiology
Division
Director, Program Management, R&D
Manager II, Program Management
• Established and managed the Program Management Office. Program managed PMA and 510k
product launches and acquisition integrations. Managed a project management staff responsible
for leading cross-functional teams to develop and deliver medical device programs. Grew the
team to a staff of 14 – 6 PMs; 5 technical writers; 3 project coordinators. Developed and
managed $40 million R&D budget.
• Facilitated executive Project Investment Board responsible for project governance. Prepared team business
reviews, communicated project status, and managed active project list to ensure continued adherence to
business strategies. Established portfolio process, working actively with senior staff, cross-functional teams,
customers, and marketing.
• Member of Boston Scientific World Wide Development Governance Board, tasked with re-
creating the development process to measurably reduce cycle time. BSC stage gate process was
re-done to focus on up-front planning and requirements definition. Instituted daily stand-up
meetings to improve team communication and time to market. The result has been up to 30%
time reduction by eliminating re-work and increasing cross-functional ownership.
• Facilitated and continuously improved the stage-gated product and technology development
processes.
• Developed and delivered training in product development processes, SOPs, project management,
and meeting facilitation.
Infogain Consulting Corporation
Manager, Project Management Office
• Established and managed the Project Management Office (PMO), to provide program consistency
and improved time-to-market. Developed project management processes and initiated project
1
December 2005 – December 2015
October 2002 – present
October 2002 – December 2005
October 2002 – present
August 1999-June 2002
2. manager training and certification program.
• Consulted with Fortune 500 clients to manage development and implementation of software
project solutions. Clients included Hewlett-Packard, Varian Medical, APL Shipping, and others.
•Gathered customer requirements, developed design documents, developed budget and timelines,
established team, managed development and test, managed implementation and acceptance,
and facilitated evaluation.
•Managed project risk, resolved issues, established change control procedures, developed
documentation, managed schedule and budget.
•Communicated project status with client, team and management.
• Established project quality audit system for project consistency and post-project evaluation.
• 6 direct reports; budgetary and P&L responsibility
Aspect Telecommunications
Senior Program Manager
• Managed global cross-functional teams to deliver 22 software application products and 3 call center solutions
to market in 3 years.
• Owned full product life-cycle including requirements definition, marketing, software development, quality
assurance, documentation, training, product support, BOMs, manufacturing, and order administration.
• Established program management processes, coached new program managers, and led program management
team.
• Consulted with customers worldwide to implement Aspect solutions. Developed new business opportunities
and established lasting customer relationships. Clients included GTE Wireless, BlueCross, TicketMaster, and
others.
• Developed market requirements documents and functional specifications; managed future product directions.
Siemens/IBM/ Rolm Communications
Program Manager
• Program managed development and delivery of call center reporting and
configuration products
• Designed and implemented call center reporting solutions for numerous
clients including Coca-Cola, Norstan, and Charles Schwab
• Established project management processes and procedures
2
November 1995-July 1999
Sept. 1988 - Nov. 1995
Oct. 1986- August 1988
3. Lockheed Missiles and Space
Program Leader
• Project managed development of Trident D5 Missile Launching systems
• Established Instructional design and training development procedures
• Managed multi-media training design and development
CDEX Intellisance
Program Manager
• Program managed instructional design and course development and
established project planning and management procedures.
National Semiconductor
Technical Training Manager
• Managed Technical Training team of course developers, writers and
graphic artists
E D U C A T I O N A N D S K I L L S
San Jose State University – MA 1980; San Jose State University – BA 1975
Additional coursework in anatomy and physiology, order and disorder in cardiac rhythm, kinesiology, regulatory
affairs, organizational development, financial accounting, training development, leadership, meeting facilitation
Project Management Professional (PMP); Member of Project Management Institute (PMI)
Certified Kepner-Tregoe trainer – Potential Problem Analysis/Decision Analysis
Certified team leader and meeting facilitator, Interaction Associates Teams in Action
Rational Unified Process (RUP), and Capability Maturity Model (CMM)
MS Project, Word, Excel, PowerPoint, Visio
3
Sept. 1985 - Sept. 1986
April 1984 - Sept. 1985