This document is a resume for Jessie Spencer-Cooke outlining her experience and skills in program management for medical device product development. She has over 30 years of experience managing global cross-functional teams and new product development from requirements through launch. Her background includes establishing program management processes and offices, managing large project portfolios and budgets, and ensuring regulatory compliance. She is a certified Project Management Professional with training in areas such as decision analysis, team leadership, and product development processes.
PRINCE2 key terms and free revision notes to pass the certification examprojectingIT
Ashish Dhoke, Project management trainer and consultant @ projectingIT, PRINCE2 ATO, presents this free exam tips, tricks and last minutes keyword revision notes materials to help pass the PRINCE2 certification exam in your first try.
If you hold PMP or CAPM credentials then you can fast-track your way to PRINCE2 certification. Download this useful guide: http://www.knowledgetrain.co.uk/prince2-guide-for-pmp-and-capm-credential-holders.php
Overview of the PRINCE2 project management framework, its history, benefits and qualifications and how it compares with the PMBoK.
Contents:
- History of PRINCE2
- The structure of PRINCE2
- PRINCE2 qualifications
- Who uses PRINCE2?
- Benefits of PRINCE2
- Which is better - PRINCE2 or PMBOK?
- Comparison of PRINCE2 and PMBOK
- The student and the doctor
- Conclusion
pmbok, pmp, prince2, comparison, prince2 project management, PRINCE2 vs PMBOK, PMI
Rate your Project manager – to express yourself RateYourPM
Project management is the planning, organizing, and managing the effort to accomplish a successful project whereas a project is a one-time activity that produces a specific output or outcome at a particular interval for benefit of the organization
PRINCE2 Overview Paradigm Consulting Group PCGIPCGI
The Paradigm Consulting Group (PCGI) is an internationally accredited consulting organization specializing in project management and business analysis.
This presentation is the first in a series that will provide an overview to project management concepts and internationally accepted best practices in the field project management
PMP Knowledge Areas - PMBOK 6 (PMI) INFOGRAPHICJonathan Donado
PMP Knowledge Areas & Process Group - PMBOK 6.0. knowledge areas
Estudy for the PMP exam by learning and memorizing the 49 process groups in PMBOK
by Jonathan Donado
MBA - IESE
Senior Executive Fellows (SEF) - Harvard University
#PMP #PMI #projectmanagement
PRINCE2 key terms and free revision notes to pass the certification examprojectingIT
Ashish Dhoke, Project management trainer and consultant @ projectingIT, PRINCE2 ATO, presents this free exam tips, tricks and last minutes keyword revision notes materials to help pass the PRINCE2 certification exam in your first try.
If you hold PMP or CAPM credentials then you can fast-track your way to PRINCE2 certification. Download this useful guide: http://www.knowledgetrain.co.uk/prince2-guide-for-pmp-and-capm-credential-holders.php
Overview of the PRINCE2 project management framework, its history, benefits and qualifications and how it compares with the PMBoK.
Contents:
- History of PRINCE2
- The structure of PRINCE2
- PRINCE2 qualifications
- Who uses PRINCE2?
- Benefits of PRINCE2
- Which is better - PRINCE2 or PMBOK?
- Comparison of PRINCE2 and PMBOK
- The student and the doctor
- Conclusion
pmbok, pmp, prince2, comparison, prince2 project management, PRINCE2 vs PMBOK, PMI
Rate your Project manager – to express yourself RateYourPM
Project management is the planning, organizing, and managing the effort to accomplish a successful project whereas a project is a one-time activity that produces a specific output or outcome at a particular interval for benefit of the organization
PRINCE2 Overview Paradigm Consulting Group PCGIPCGI
The Paradigm Consulting Group (PCGI) is an internationally accredited consulting organization specializing in project management and business analysis.
This presentation is the first in a series that will provide an overview to project management concepts and internationally accepted best practices in the field project management
PMP Knowledge Areas - PMBOK 6 (PMI) INFOGRAPHICJonathan Donado
PMP Knowledge Areas & Process Group - PMBOK 6.0. knowledge areas
Estudy for the PMP exam by learning and memorizing the 49 process groups in PMBOK
by Jonathan Donado
MBA - IESE
Senior Executive Fellows (SEF) - Harvard University
#PMP #PMI #projectmanagement
La Alianza por el trabajo es la unión de voluntades políticas e institucionales para articular e impulsar la generación de trabajo en el país, con los actores más vulnerables del territorio nacional. Integrada por instituciones públicas, privadas y académicas alineadas a la visión política y social de apoyo a la EPS, lideradas por el: MDT – MSP – SERCOP - MCTH
Finanzas Populares y Solidarias y la articulación con los Actores Locales
Forma de organización económica donde sus integrantes, organizan y desarrollan procesos de producción, intercambio, comercialización financiamiento y consumo de bienes y servicios para satisfacer necesidades y generar ingresos, basada en relaciones de solidaridad, cooperación y reciprocidad, privilegiando el trabajo y el ser humano.
Corrigiendo escenarios y proyecciones, se puede esperar un quinquenio con retos para Ecuador. Gestionar alianzas solo público-privadas (public-private partnerships) no será suficiente. Se requerirá alianzas inter-sectoriales (cross-sector partnerships). Lo macro se cura desde lo micro, desde los fundamentos, desde la generación de acuerdos.
Mep Middle East Featuring DC PRO EngineeringGeorge Berbari
DC PRO Engineering is Pushing the boundaries of District cooling and Tri-Generation with more than 2.6 Million Refrigeration Ton designed so far probably the largest in the world.
Dinesh Kumar: Experienced Medical Device Project Manager ResumeDinesh Kumar
This presentation encapsulates the professional portfolio of Dinesh Kumar, a dedicated and results-driven Project Manager with extensive experience in the medical device sector. Specializing in leading projects from ideation to execution, I have a proven track record in enhancing product development processes, optimizing project workflows, and ensuring compliance with industry standards. My expertise includes cross-functional team leadership, strategic planning, and stakeholder management, underpinned by a strong commitment to advancing healthcare innovation. Here, you'll find a detailed overview of my project management methodologies, leadership philosophy, and the key achievements that have marked my career in medical device development. This resume is a testament to my ongoing journey in contributing to healthcare advancements through rigorous project management and innovative thinking https://www.linkedin.com/in/dineshkumar-medical-project-manager/
Presently working with M/S. Sheetkraft India Pvt. Ltd. (A Joint Venture Manufacturer of VEEGEE Group) From Feb - 2017 to till date, as a Plant Head (Operation). Company Profile is 100% Manufacturer for Maruti Suzuki and Honda for Sheet Metal Process. Faridabad Base Group of Industries for Direct Manufacturer of Automotive Parts.
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