RKT Engineering,
Inc. / RKT Technologies, Inc., Londonderry,
NH
September 1977 to Present
In 35
years as Owner and President of RKT Engineering,
Inc. (a Massachusetts corporation) and its successor
corporation RKT Technologies, Inc. (a New Hampshire
corporation), I have provided hardware and software
design consulting and technical services to a number
of companies in the Greater Boston and Southern New
Hampshire area and elsewhere in the Eastern and
Central USA. Highlights in approximate reverse
chronological order (except where indicated):
- (2015) Performed an independent code review
and provided corrections for faults found in software
for a class 2, major level-of-concern,
critical-life-support medical device.
-
Performed a comprehensive independent software review
consisting of design review, code inspection, and
static and dynamic code analysis.
-
Advised and provided corrections for literally
thousands of issues found in more than 200,000 lines
of code proving once again that this type of review
and verification needs to be done on an ongoing basis
during all phases of development, and not postponed to
the end.
-
Identified some hardware issues that manifested
themselves as software bugs, and provided
recommendations for correction.
-
Performed an analysis of USB 2.0 traffic flow and
interface to USB 2.0 devices, using a USB 2.0
protocol analyzer. Provided the protocol analyzer
used in making this analysis.
-
Software is in C++ on the QNX RTOS and Momentics
IDE, making extensive use of C++ templates.
Hardware uses multiple processors (TI iMX-53,
2x68332, 8051) communicating with one another via
serial, USB, and SPI bus.
-
Guided the migration of the project to Subversion
(revision control system) and Bugzilla (bug /
action item tracking). Hosted, configured,
administered, and maintained the projects
Subversion and Bugzilla servers.
- (2015) Organized and served as co-producer and
co-moderator for a public forum and presentation on how
to apply Agile software development to medical devices
using AAMI TIR-45:2012, presented by the Medical
Development Group of Boston (www.mdgboston.org). My
responsibilities included recruiting speakers,
researching subject matter, identifying the target
audience, producing advertising materials, and
monitoring progress so that everything was completed on
time.
- (2014 - 2015) Providing software regulatory and
independent-review consulting services on class 2 /
510(k) and class 3 / PMA medical device products.
- (2009 - 2012) Developed a user interface
and served as a software and regulatory consultant
and software team leader for a class 3 medical
device that delivers RF energy to the
patient. Recruited, and provided leadership
and supervision to, a team of 3 senior software
engineers and 1 senior software quality assurance
engineer. Software development was in C++
for MicroC/OS-II, and design used Unified Modeling
Language on Sparx Systems Enterprise
Architect. Device made it through FDA PMA
Supplement approval in half the normal time.
- (2008 - 2009) Implemented a master-slave
communications system on an infusion pump for
veterinary use; software development in C for
FreeRTOS. Provided regulatory consulting services to
that client as they evaluated whether to certify the
infusion pump for human use.
- (2008) Served as software quality assurance and
regulatory consultant for a collaboration among a
number of university research centers to develop
an artificial pancreas for Type 2 diabetes
sufferers.
- (2007 – 2008) Performed a full requirements
analysis and top-level design for a digital
communications system for Boeing 757 airliners and
freighters being developed to FAA DO-178B
standards, using C++
on MicroC/OS-II operating system. Client
retained my services in doing the requirements
analysis while they searched for a qualified
permanent employee to continue the development.
- (2007 – 2008) Served as independent software
quality assurance analyst for a new type of ice
cream vending machine; system used a Linux-based
multi-tasking software package driving custom
hardware to dispense individual servings of ice
cream of the customer’s choice of flavors and
mix-ins.
- (2007) Performed a major software rehabilitation
and refactoring project on a complex machine
vision system whose software documentation has
become obsolete, and the C++ software has become
unmaintainable.
- (2005 – 2006) Served as senior software engineer
for a multi-device, multi-node Voice over IP
communications network implemented on embedded
Linux in C++.
- (2004 – 2005) Designed and implemented the
software for a feasibility prototype of a SCADA
(Supervisory Control And Data Acquisition) system
to monitor and control the operation of appliances
in a shipboard galley for the US Navy. System was
implemented using the Iconics Genesis32 SCADA
platform and Visual Basic code. Also served as
advisor for system- and hardware-related issues.
- (2004) Hired to perform a major system upgrade
to a Night Targeting System Upgrade Kit for
helicopter flight simulators that I had developed
in 1995-1997. Original project was developed to
run across three separate processors, with two of
the three processors executing single tasks. This
year’s upgrade involved moving to a new, faster
CPU with a single processor. This required an
extensive restructuring of the system software to
run in multiple tasks (a total of 19 prioritized
tasks) on VxWorks 5.5.1 using Tornado 2.2.1 as
IDE.
As part of this project, I designed and wrote a
multi-tasking data simulator on Microsoft Visual
Studio / Visual C++, to send and receive
formatted data concurrently across 6 serial
ports to the target system. This tool involved
creating several dialog boxes to configure the
outgoing messages and specify the expected
configuration of the incoming messages.
- (2003 – 2004) Served as Principal Software QA
Engineer for a new type of endoscope. Duties
included making sure that the software
development was in full conformance to the FDA
Quality System Regulation / 21 CFR 820, ANSI /
AAMI SW-68, ISO 14971, 21 CFR 11, and each of
the stakeholders’ internal Standard Operating
Procedures. Also served for a time as acting
Software Project Engineer for the project, with
duties that included managing the activities of
a group of off-site software developers, and
assisting in defining the job description and
qualifying a permanent employee to take over
that role.
- (2001 – 2003) Software architect and key
software developer for a navigational system for
installation on oceangoing ships. Also served as
mentor to other software engineers in the areas
of C++, VxWorks, Tornado, and Unified Modeling
Language (UML).
- System provides a central redundant
fault-tolerant computer that takes inputs
from Inertial Navigation Systems (INS),
Global Positioning Systems (GPS), depth
sounder, magnetic compass,
speed-through-water sensor, and redundant
weather sensors, and outputs information to
shipboard displays and other shipboard
systems.
- Central computer provides services
including Dead Reckoning capability so that
the ship’s position could be estimated in
case of failure of the INS and GPS.
- Central computer consists of two PowerPC
processors in a CompactPCI chassis.
- Designed central computer software using
UML on Rhapsody Modeler with implementation
in C++ on VxWorks 5.4 and Tornado 2.1.
- Designed and implemented a graphical
display on Linux / Xfree86 using a TCP/IP
network connection to display the real-time
value of variables in the VxWorks target
system software, for use in debugging and
verification.
- Provided code modification and code review
services and assisted in testing and
debugging of the Graphical User Interface
(GUI) for this system, which was implemented
on a ruggedized PC using Microsoft Visual
C++.
- (2000 – 2001) Key
software developer for a Voice Over IP (VoIP)
test system for use in testing and validating
VoIP gateways.
- Platform was
PowerPC on CompactPCI and VxWorks with
development under Tornado 2 in C and C++ using
Object Oriented Analysis, Design, and
Programming (OOA/D/P) including UML and Use
Cases.
- Designed and
implemented some simulation and test software
on Linux / Xfree86.
- Served as mentor
and instructor to other software engineers in
the areas of VxWorks and real time
programming.
- Served for a time
as acting Principal Software Engineer /
Technical Lead for this project while the
client went about the process of hiring
someone on a permanent basis to assume that
role.
Summary of
activities prior to 2000
Following is a brief summary
of projects completed prior to 2000. Details on each
of these projects are available on request.
- (1999) Cardiac medical
device; software modifications; PIC assembly
language
- (1999) Medical device
for ophthalmic surgery; specification; IV&V;
regulatory consulting
- (1999) Avionics;
software test tool modification; Visual C++
- (1998 - 1999) Medical
device; software development / refactoring /
regulatory consulting; C; personnel search
consulting
- (1998 - 1999)
Military; software development; C / VxWorks
- (1997 – 1998) Medical
device; software QA / IV&V; C++
- (1997) Military;
software QA; system and software specifications
and design
- (1997) Avionics;
software specification
- (1997) Government
(NWS); user interface design; C
- (1996 – 1997) Medical
device; software IV&V and defect repair; C
- (1995 – 1997)
Military; software development; C / VxWorks
- (1994) Telecom
switching; software development; C and 80x86
assembler
- (1994) Avioinics;
software QC / testing
- (1994) Medical device;
independent software design/documentation review
- (1993 – 1994) Medical
device; software development; Borland C
- (1992) Medical device;
hardware and software development; C
- (1991) Industrial
machine; hardware and software development; user
interface
From 1977 to 1991, completed
numerous system, hardware, and software development
projects in areas such as industrial controllers and
voice / data security systems, using C and assembly
language on a variety of microcontrollers. Details are
available on request.
REFERENCES: Available on request.
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