Manager Engineer
Resume:
Donald J. Shave
Hartland, WI 53029, USA
Office: +1-262-***-**** Cell: +1-262-***-****
eMail: **.*****@*****.*** Web: www.linkedin.com/in/DonShave www.Creative-Logic-Software.com
Objective secure a position in a dynamic organization that is seeking a person with a remarkable record of
compliance-driven program/process/people leadership, software applications, systems & software V&V;
medical imaging device development and solutions for computer security problems and new web designs.
Experience/Skills Summary professional engineer in medical device development, experienced in product
development, management and regulatory compliance. Expertise with C/C++, VB++/VBA, Java (Eclipse,
ANT), Windows- and Java-script, Excel-based tools/apps; Microsoft Office suite; GE s eNPI, PRD, eLibrary
& others, Oracle/Cube, PROMIS/APF; 21CFR/ISO13485; Six-Sigma & Lean process improvement
techniques. Personable, credible, experienced and passionate; attention to detail; willingness to engage
challenging assignments; definition of new processes, tools & software to address key business problems.
President & CEO, Creative Logic Software, LLCApril 2009Present
o Consulting services utilizing compliant processes are provided for leadership of projects, programs &
people; for software expertise in data-mining networked, local or paper data; for validation of systems &
SW with an extensive knowledge base; and for medical imaging device development.
o Solutions to PC computer security problems and for new web designs are also provided.
GE Healthcare, Waukesha, WI
Six-Sigma & Software Engineer, Global Imaging SubsystemsSeptember 2007April 2009
o Designed/deployed an automated tool to display feedback to technicians operating the semiconductor
fab (clean room) at a California supplier improved overall production yield of these $100k ICV parts.
o Other key roles included development of a CAN bus interface to a collimation device for the detector
Tester system to address an upcoming obsolescence issue. Used a commercial USB-based IXXAT
driver with C++ on Windows platforms. Fully compliant to 21CFR with formal, controlled documentation.
Lead Quality Engineer, CT & PET Business February 2001 September 2007
o Led multiple cross-functional global teams to successfully pass many Quality Management System
audits (FDA, GMed, UL, ISO & self-audits). Drove implementation of process improvements globally to
address resolution of numerous non-conformance & CAPA findings that were tracked/closed.
Manager of Engineering Staff, CT Business January 1999 February 2001
o Senior staff role, leading global process development/implementation of business-critical operational
activities; responsibilities included prediction, control and management of budget, headcount, program
planning, facilities and others. Managed >$40M global budget to quarterly/year-end targets. Created
automated tools (Excel-based VBA) to facilitate staff leaders with headcount, budget and other targets.
Program & Project Management, Global X-Ray July 1993 January 1999
o Global program leader for development & introduction of a Tilting C-arm X-ray product; a 3-year project
with a $7MM+ development budget and a cross-functional global program team of over 120 people.
o Completely revised system installation approach, saving time & money and improving quality to the
customer; work was recognized with a substantial management award and GE stock options.
o Multiple other roles were held in this timeframe and in earlier roles with GE.
Education
Enrolled in a BSCS program at Carroll University, Waukesha; 2011 target, GPA at 3.4 of 4.0
Graduated with high honors from the Computer Data Institute, London, England
Graduated with high honors from the British Army Apprentices College, Harrogate, England
Additional information is available on request
Detailed Work History for Don Shave
Page 2 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Apr, 2009 Creative Logic Software, LLC President & CEO
to date Hartland, WI, USA - Consulting services are provided by my business using processes
Self-employed ensure compliance to all required regulatory agencies for
projects, programs & people; for software expertise in data-
networked, local or paper data; for verification and validation (V&V)
systems & software with an extensive knowledge base; and for
imaging device development.
- Solutions to PC computer security problems and for new
are also provided.
Mar, 2008GE Healthcare, Global Imaging XRD Tester System Software Engineer
Apr, 2009 Subsystems, X-Ray Detectors - Design and deploy critical changes to key
HQ, Waukesha, WI system required for compliance of manufactured XRD digital panels.
Gil Wu
Accomplishments
- Finalized
an engineering tester system tool
system team
for development work, and is built with Microsoft Visual Basic
on the Win2K platform. As I developed
found and addressed multiple missed development issues with the GUI
the system requirements, the software design and the verification plan;
- C
collimator to address an
NSI board interface; this used a commercial USB-
The
above. Despite
persisted with my approach, resolving this with support from IXXAT
compliance with 21CFR was achieved in the same way as above.
The release of this tool has been
configuration package for a new tester PC and is in use today.
-
of acquired X-
established industry standard open-
built in Java, using the Eclipse SDK on a Windows XP platform,
ClearCase is the SCM. The business justification fo
platform;
product release.
that
leadership of
mining
of
medical
web designs
functions in the tester
the incomplete compliance remediation tasks from 2 007 for
which is in daily use by the Tester
. This tool provides a GUI access to all system fun ctions
6, running
the verification plan for the tool, I,
meeting compliance to 21CFR with controlled formal documentation of
reated an additional CAN bus interface for the test er system
upcoming obsolescence issue with the current
based IXXAT driver.
interface was built using Microsoft Visual C++ 6 on a Windows
2000 platform, meeting compliance in the same way a s described
significant obstacles presented by the team when I
uncovered a critical compatibility issue during the development, I
;
deployed with the standard
Developed the initial phase of a replacement imagi ng tool for display
Ray digital images, based on the ImageJ platform, a n
source tool that was developed at
the National Institutes of Health for imaging in ge neral. The tool was
r the project was
based on a need to eliminate annual licensing costs for the existing IDL
I met both cost and a difficult schedule demand wit h this task. As this
project was part of an assessment, work is needed t o add features for
Detailed Work History for Don Shave
Page 3 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Sep, 2007 GE Healthcare, Global Imaging XRD Yield Green Belt
Quality, Validation, 6 Sigma &
Mar, 2008 Subsystems, X-Ray Detectors - Drive reductions in manufacturing yield issues at GE s
HQ, Waukesha, WI detector panel supplier.
Kay Schmidt Accomplishments
PKI, Santa Clara, CA
John O Donnell -
the FAB, provided the oper
at each station and shift for the prior 24 hours and the prior 13 weeks.
appro
controlled by Windows scheduled tasks at each station.
embedde
displayed and other settings.
continuous feedback to the operators of both short- and long-
results of their daily activities, and is in use today.
Dec, 2006GE Healthcare, Central QA QA Manager (acting)
Sep, 2007 HQ, Waukesha, WI - Managed compliance tasks for engineering programs
Levi McKelphin Accomplishments
- QMS deployment and enforcement for MICT engineering
Jun, 2004GE Healthcare, Global FCT & Engineering Quality Leader
Dec, 2006 Global MICT Engineering - Define & deploy key processes, training & coach
HQ, Waukesha, WI engineering aspects of the QMS
Karen Fleming Accomplishments
Gary Strong - Focus on compliance for CT & PET Engineering
Jan, 2004GE Medical Systems, Global Manager, FCT IBQ Engineering
Jun, 2004 FCT Engineering - Managed consolidated
HQ, Waukesha, Wi US & international folks
Mike Fritts - Supported compliance & other areas
Accomplishments
-
around FCT s IB of >35,000 systems
- Continued with an also-increasing load of back-
compliance ( FDA s coming ), training, facilities, & staff
Jun, 2003 GE Medical Systems, Global Global Manager, CT Customer Centricity
Jan, 2004 CT Engineering - Addressed Compliance across the board (on demand)
HQ, Waukesha, Wi -
Bob Armstrong hiring some folks & working the process
- Allowed both Validation & 6-Sigma to continue on their current track
Accomplishments
- Managed a team with four key areas: IB
Compliance
- Continued back-office support for staff
key digital
Designed a fully automated multiple PC platform to ol to display
effectiveness data (OEE) to the technicians who ope rated the
semiconductor FAB. The displays, mounted near each LITHO station in
ators with sequential displays of vertical bar
graphs showing uptime, planned downtime and unexpec ted conditions
Full automation for this tool was achieved using a master/slave
ach, with a command directive file on a common serv er that is
written by the master station; the tool is initiate d, terminated and
The tool is structured around a single Excel spread sheet with
d VBA code that resides on the common server; each station
has a configuration file, defining the master stati on, what is to be
The intent and business justification for this proj ect was to provide
term
ing around key
IB teams for CT, PET & Nuc in Mke as well as
Managed the FCT IB Quality team with incessant, in creasing issues
office support for
Grappled with the growing burden from CSOs, PQRs & PSRs by
d new program processes/process improvements and to ols
Detailed Work History for Don Shave
Page 4 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Feb, 2001GE Medical Systems, Global Manager, CT Quality System
Jun, 2003 CT Engineering - Staff role leading quality-oriented
HQ, New Berlin & Waukesha, Wi implementation for business-
Bob Armstrong
budget, headcount, program planning, facilities and other areas
- GTO-wide eEng role, including work on eNPI & ePRD
- Deployed processes & tools for financial control as well as web-
reports for heads, materials, T&L expenses and others
-
Continued delivery of these key operating mechanis ms and tools
despite significant personal medical complexities
Accomplishments
-
reach global areas.
- Managed annual Base-cost Budget to quarterly & Y-
2001 annual budget $48MM.
- Deployed financial tracking processes & tools to f
Engineering budget predictability and allow control.
- Managed WWPP, OP & other product planning tools/processes.
-
(web and non-web) to support them.
Oct, 2000 GE Medical Systems, Global Manager, CT eEngineering -
Feb, 2001 CT Engineering
HQ, New Berlin, Wisconsin business-critical operational & administrative
Bob Armstrong prediction,
planning, facilities & others
- GTO-
ePDM (Legacy Apps).
- Deployed processes & tools for financial control & web-
for heads, materials, T&L expenses and others. -
despite significant personal medical complexities.
Accomplishments
- Managed annual Base-cost Budget to quarterly & Y-
2000 $41MM & 2001 $48MM.
- D
Engineering budget predictability and allow control.
- Managed WWPP, OP & other product planning tools/processes.
-
(web and non-web) to support them.
Jan, 1999GE Medical Systems, Global Manager, CT Product Planning/NPI Process -
Oct, 2000 CT Engineering
HQ, New Berlin, Wisconsin business-critical operational & administrative responsibilities.
John Chiminski Accomplishments
Bob Armstrong - Deployed processes & tools for financial control as well as web-
reports for heads, materials, T&L expenses and others.
- Managed annual Base-cost Budget to quarterly & Y-E targets.
1999 $23MM (Mke), 2000 $41MM Globally & 2001 $48MM.
-
Engineering budget predictability and allow control.
- Managed WWPP, OP & other product planning tools/processes.
- Develope
(web and non-web) to support them. -
despite significant personal medical complexities.
process development &
critical operational & administrative
responsibilities including prediction, control and management of the
based
Continued delivery of these key operating mechanis ms and tools
Managed all aspects of the Quality System for CT. Extending role to
E Global targets:
acilitate overall
Developed new program processes/process improvemen ts and tools
Staff role leading process development and impleme ntation for
responsibilities including
control & management of budget, headcount, program
wide eEng role defined including work on eNPI, ePRD, and
based reports
Continued delivery of these key operating mechanis ms and tools
E Global targets.
eployed financial tracking processes & tools to fac ilitate overall
Developed new program processes/process improvemen ts and tools
Staff role, leading process development and implem entation for
based
Deployed financial tracking processes & tools to f acilitate overall
Detailed Work History for Don Shave
Page 5 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Oct, 1998 GE Medical Systems, Global Emperor Global Program Lead
Jan, 1999 X-Ray Systems Engineering - Global Program Manager role for fast-track NPI w
HQ, Waukesha, Wisconsin team in Beijing, China. Global RAD value-
Carol Murawski market; GEMS did not compete in this market segment.
Jean-Yves DiBartolomeo -
(dotted line) new product at RSNA.
Jim Bland (dotted line) - Team recognized for Competitiveness with ALL-STAR award.
Dave Mliner (dotted line) - Personal leadership recognized with Management Award.
Accomplishments
- Provided program leadership to fast-
deliver milestones to plan.
Apr, 1998 GE Medical Systems, Global Apollo Feasibility Sys Service Integration Lead
Dec, 1998 X-Ray Systems Engineering - Small team LPI rol
HQ, Waukesha, Wisconsin organization and leadership to ensure uptime & Customer sat.
Carol Murawski -
Sonia Dubreuil (dotted line) organization (AACP).
Fabrice Rousseau (dotted line) Accomplishments
- Provide leadership to growing team; ensure
customer, transition to centralized team.
Jan, 1998GE Medical Systems, Global SenoVision Mammography Supplier Lead
May, 1998 X-Ray Systems Engineering - Off-p
HQ, Waukesha, Wisconsin team for critical US supplier in Long Island, New York.
Carol Murawski - Developed and executed recovery plan with supplier.
Sonia Dubreuil (dotted line) Accomplishments
-
program schedule.
May, 1997 GE Medical Systems, Global Global I&W 6-Sigma Champion
Dec, 1997 X-Ray Uptime Systems Design- LPI role for all deliverables related to Global cost reduct
HQ, Waukesha, Wisconsin Installation & Warranty expenses for the Vascular business.
Tracy Accardi -
Jeff Pelletier resource requirements, and deliverable timing for over 70 key activities.
Davy Hwang (dotted line) Accomplishments
- Coordinated and drove global 6-
reduction in 1998. Transition lead role to Buc team for execution.
ith development
tier offering in $200MM
Delivered milestone MR/MS (announcement) and M3 (p ilots) Showed
track global team in 3 poles, lead
service deliverables, ensure issues reach rapid clo sure, organize and
e for Apollo feasibility sites in US, providing
Developed communication processes, WWW plans and s cope of new
rapid service response for
ole LPI role to GEMSE Mammography NPI SenoVision pr ogram
Led supplier recovery to meet deliverables and res tore missed
ions for
Developed detailed project scope report, including estimated savings,
Sigma activities for Installation and
Warranty cost reductions to meet GDXR business goal of $7MM
Detailed Work History for Don Shave
Page 6 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Jul, 1996 GE Medical Systems, Global Vascular Americas Leader
Up to 15 people in my functional unit; developed p lans and work
Sep, 1997 X-Ray Vascular Program - LPI for New World Program. Drove redefinition of 2-year-
Management back to re-approval of M0, on track for M1 and execution wi
HQ, Waukesha, Wisconsin
Davy Hwang Engineering resources globally on completion of business-
Tracy Accardi program. -
John Chiminski (dotted line)
Dow Wilson (dotted line) evaluation files in support of FDA/ISO inspecti
assignments, performance appraisals, salary plans, budgets, & other
testing. -
for multiple concurrent Vascular FMIs.
- $3.5MM LCA M4 FMI deploying to 110 customers world-wide;
Most complex FMI ever deployed at GE Medical Systems.
Personal leadership recognized with Management Award.
- V3 XRT FMI deploying globally to 325 Vasc & R&F customers
- Other Vascular FMI s deploying to 250+ customers
Accomplishments
- Key
program rollout and IB Customer Satisfaction. -
in share growth for Vascular business in 1997.
Jul, 1993 GE Medical Systems, Global TC Program LPI -
Jul, 1996 X-Ray R&F Program
Management Tilt-C, a new type of X-
HQ, Waukesha, Wisconsin Procedures.
Bob Hauck - New entry to $1,50MM+ market for GEMS.
Paul Hartke - 3-year/$7MM+ development, with a cross-
Srini Seshadri (dotted line)
Dow Wilson (dotted line) geographically split around the US and Europe.
- Full production achieved within 3 months of original plan date.
- Leadership recognized with significant Management Award.
Accomplishments
- Key leader in all phases of program through production
- Champion & change agent for internal process improvements:
- Changes in engineering program management techniques
- Automated system validation techniques (cycler)
- Cost prediction and management tools (Q&P sheet)
- Completely revised system installation approach (SCAT),
saving time & money and improving quality to the customer
Jul, 1990 GE Medical Systems, X-Ray Engineering Functional Manager
Apr, 1994 Waukesha, Wisconsin - Rebuilt X-Ray group software staff, hiring 20 engineers in 1 year.
John Raker - Led continued software development process improvements; ISO-
Wes Klages 9001 process representative for software group. -
Claude Benchimol
Emmanuel Derome cluster subgroups and leaders.
- Resolved issues with several poor performers in my group.
- Functionally responsible for many concurrent software projects.
Accomplishments
-
businesses, as well as Apollo and InSite projects.
- Concurrent TC program leadership responsibility (see below).
-
administrative tasks.
old program
th new
deliverables. Program suspended Sep/96 to utilize a ll Vascular
critical LCA
LCA Sys Eval Lead. Led audit of GEMSE Systems Engi neering
on. Leader for America s
systems evaluation team, driving clinical scenario evaluation and
Global Vascular FMI Coordinator. Led development a nd deployment
leadership role in Global Vascular Business Team w ith focus on
Resolution of quality issues in the Vascular IB re sulted in turnaround
New Product program team leader, developing and in troducing the
Ray system for clinical & surgical Interventional
functional program team of
over 100 people at peak, as well as several major s uppliers,
Developed reorganization concepts for group, inclu ding software
America s pole software deliverables for all proje cts in R&F/Mobile
for large computer installations at the
Detailed Work History for Don Shave
Page 7 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Jan, 1987GE Medical Systems, X-Ray Senior Software Systems Analyst -
Jul, 1990 Waukesha, Wisconsin
John Raker ADVANTX product line. This is a large X-
system (over 5MM lines of code) with a networked multi-
processor/multi-
architecture is based on Intel 80x86 P-
lines of PLM-86 code in each device.
develop real-time softw
for each positioning device. -
processes for software design and development.
- Software coordinator for Model Period 7, a major ADVANTX
needs and issues to cross-functional groups (Mktg, Mfg, Svc, etc.)
Accomplishments
-
3* year period in a number of areas of the ADVANTX
X-Ray control software system, with teams of up to 25 engineers.
Mar, 1985Creative Logic Software Consultant
Jan, 1987 Washington, D.C. area - Designed and implemented real-time software programs:
(Self-employed) A custom BIOS for an IBM-
upgrades for a communications encryption unit and a commu
message switching system.
- Analyzed and documented real-
of a TDMA communications node. -
services for a State Government Health Department.
- Developed real-
and installation of an X-
device (the 8835 Spot-filmer).
Accomplishments
-
computing services to several different companies.
Nov, 1981Fairchild Corp. Software Engineer
Mar, 1985 Maryland - Designed/implemented embedded real-time control applications:
Ken Grish Avionics Reconnaissance Sensor Control Subsystem
MIL-STD-1553 Bus Control & Monitoring Unit
16Mbps Satellite TDMA Communications Encryption System
Remote-site Diagnostics Package for a large communications network
Accomplishments
-
for overall systems and software design, timely delivery of high-
configuration management of all project software.
Apr, 1978 Burroughs Corp. Computer Field Service Engineer -
Nov, 1981 Midland Bank HQ, London
Eric Burnett diagnostic software.
HQ, World Bank, Washington Accomplishments
D.C. - Overall responsibility
Jack Curtis headquarters of The Midland Bank in London, England,
and at the World Bank headquarters in Washington, DC
- Provide leadership, training & direction to teams of FE s
Software team leader for several positioning devic es for the
Ray diagnostic imaging control
tasking architecture. The positioner subsystem
processors, with up to 100,000
Team leader of up to 8 software engineers with seve ral suppliers to
are for applications, diagnostics and calibration
Lead role in the software group for redefining and improving critical
product
release, planning/executing all software deliverabl es. Drove significant
process improvements related to this position; coor dinated and directed
the activities of 25 engineers, as well as communic ating all software
Technical/project leadership of varied software de velopments over a
PC compatible service training computer,
nications
time software for several subsystems
Developed a custom computer accounting system & pr ovided training
time software to provide service tools for calibrat ion
Ray ADVANTX Diagnostic Imaging positioning
Managed a successful independent business providin g varied
Lead Engineer for teams of up to 8 software engine ers. Responsible
quality
product software, planning and coordinating team me mbers' work,
training and technical reviews of team members & ot her engineers, and
Maintenance of mainframe CPU's & intelligent perip herals. Developed
Detailed Work History for Don Shave
Page 8 of 8
DATES Component/Location, Position / Role
Manager Accomplishments
Sep, 1977 Control Data Institute Scholar
Apr, 1978 London - Maintenance and Programming of various computer devices.
Computer Maintenance School - UK Government-sponsored Trade School.
Accomplishments
- Graduated with High Honors
Dec, 1970 British Army Communications Operator -
Oct, 1977 Royal Corps of Signals
Ireland and West Germany.
- Graduated with High Honors from the Army Apprentices College.
Accomplishments
- Maintained & Operated military armored vehicles and various ra
teleprinter, and FAX equipment.
- Promoted in May 1975; placed in charge of a 3-
detachment reporting to a Brigade-level Officer
1967-1970Several Hotels & Restaurants; High School & Summer Jobs
Family Businesses - Worked Hotel & Restaurant kitchen jobs.
Bournemouth, England - Maintained gardens with my father s landscaping business
- Apprentice Electronics Technician at my uncle s store
Established and operated military radio networks i n England, Northern
dio,
man independent
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