- Software development for medical devices and
other regulated industries.
- Real time embedded systems software design
and development using commercial and custom
multitasking real time operating systems
- Independent verification and validation of
software development processes.
- 45 years' experience in the electronics
39 years' experience in embedded systems hardware
and software design.
35 years' experience as an independent consultant.
- Specializing in C and C++, on a variety of
microcontrollers and microcomputers small and
Product Development: Experienced in designing, implementing, and documenting
software for medical devices requiring approval under the FDA Quality System
regulation; avionics devices requiring FAA TSO approval; and military
devices developed using IEEE/EIA 12207 and IEEE Software Engineering
Standards as guidelines.
- Methodologies: Structured Analysis and Design
(SASD); Object Oriented Analysis, Design, and
Programming (OOA, OOD, OOP), Unified Modeling
- Target systems: ARM series, Cortex, 80x86, 68xxx, Z80 and
variants, 8051 and variants, PIC series, Linux,
- Operating Systems and Platforms: QNX / Momentics, MicroC/OS-II
and FreeRTOS on IAR Embedded Workbench,
VxWorks / Tornado, MS Windows (Microsoft
Visual C++ / Visual Studio), Unix, Solaris, Linux
Multi-processor systems using sockets, shared memory, async and sync serial,
USB, SPI, I2C for inter-processor communication.
Standards: FDA Quality System Regulation (21CFR820), ISO 13485, ISO 14971,
IEC 62304, AAMI TIR45:2012, IEEE SE; DOD STD 2167A; RTCA/DO-178A/B; MIL
STD 498, ISO 9001, IEEE/EIA 12207, ANSI/AAMI SW-68
- Verification and Validation - Experience as an
Independent Verification and Validation Reviewer
for software developed in regulated industries
such as medical devices, with responsibilities
- Verification and Validation of software
- Serving as moderator and independent
reviewer at design reviews
- Evaluating and recommending changes and
additions to software policy documents.
- Networking: Voice over IP (VoIP), TCP/IP, SCADA
Setup and administration of Subversion and Bugzilla installations for
revision control and bug / action item tracking across projects.