Technical/Managerial Skills

Lead and manage Electronics and software engineering resources and projects to assure Software Quality Assurance and software development life cycle in accordance with IEC 62304 for medical device software development

Subject Matter Expert on design, development and manufacturing of Class II medical devices in accordance with ISO 9001/13485 and FDA regulations for Design Controls (21CFR 820.30)

Full knowledge of Root Cause Analysis tools (Contradiction Matrix, 5Ys and Fishbone/Ishikawa diagram), and Design Failure Mode and Effects Analysis (DFMEA)

Knowledge of Regulatory requirements for medical device software and 510K submission

Full knowledge of Waterfalls and Agile development processes and methodologies

Solid experience with Embedded Microcontroller Systems, ANSI/Embedded C and assembler languages for 16-32 bit embedded RISC/CISC Microcontrollers including Infineon 1767 Tri-Core, ST Microsystems ST10F269/272/273, Texas Instrument TMS320C50, TMS320F206, TMS320C25 DSP Controllers, and Motorola HC11/HC12 microcontrollers

Professional History

Principal Engineer, INVACARE Corp. Elyria, OH (9/2012 – Present)

Core position responsible for establishing and implementing FDA compliance software development process based on FDA 21 CFR 820 ISO 9001/13485 Medical Devices - Quality Management Systems focusing on 21CFR 820.30 Design Controls Procedures for the development of Respiratory and Power Wheel Chairs products. Procedures include Design Planning, Design Inputs, Design Outputs, Design Review, Risk Analysis, Design Verification and Validation

Lead a team of engineers and contractors to review existing documentation for current products and organize it in a manner that meets the requirements of 21 CFR Part 820.30

Provided overall project leadership and support for all work products related to computer system validation of Software Revision control tool, Source Gear Vault Pro, used by the Invacare Control System Group to automate software version control during the software development life cycle

Technical Staff and Lead Software Engineer, BWI Group (formally Delphi Energy and Chassis) Dayton, OH (5/2001 – 9/2012)

Managed all microprocessors’ software related activities and configuration management of all Suspension Control projects at BWI. Activities included management of software tasks of a global software engineering group

Delegated and managed execution of Software Change Requests (SCRs) for development and production to meet project deliverables and timing

Collaborated with Software Leadership Team in leading migration to new SPICE compliant software development process

Supported software verification and validation processes, including design reviews, code reviews, unit testing, creation of software test plans and issuing of reports

Lead and managed the software development lifecycle (SDLC) of controlled suspension embedded microprocessors based projects

Provided technical lead software support for microprocessor-based controlled suspension products including MagneRide™, the world’s most advanced production Ride Control System

Prepared software development documentation including software development plans, requirements specifications, software test plans, and software architecture specifications

Ensured that all software deliverables were completed on time per the project schedule and meet Software Engineering quality standards (CMMI, SPICE)

Embedded Software Engineer, Delco Electronics Kokomo, IN (7/1995 – 5/2001)

Researched and developed Embedded Control Systems for automotive suspension using Texas Instrument TMS320C50, TMS320F206, TMS320C25 DSP Controllers, Motorola HC11/HC12 microcontrollers, and ST10 microcontroller

Project Leader/Engineer, Electronic Meters, Inc. Newark, OH (5/1994 - 6/1995)

Designed microcontroller-based data acquisition and security devices systems using Intel AMD29000 and 8031/51 microcontrollers

Graduate Research Assistant, University Of Dayton

Electrical Engineering Department (6/1990 - 12/1993)

Designed a real-time monitoring system for RISC-based microprocessors and investigated the monitorability of such processors in real-time environment

Graduate Teaching Assistant, Wright State University (9/1987 - 8/1989)

Electrical Engineering Department

Taught undergraduate lab courses in Electrical Engineering (VLSI, Pulse and Digital circuits, Linear Integrated circuits, and AC/DC circuits)

Education

Ph.D., Electrical Engineering, University of Dayton

Dissertation Title: "A New, Non-Intrusive Architecture for Software Monitoring of Microprocessor Based Systems"

M.S., Applied Mathematics, University of Dayton

Research Clinic: "Introduction to Neural Networks and Adaptive Filtering"

M.S., Electrical Systems Engineering, Wright State University

Thesis Title: "A CMOS Analog Integrated Library"

B.S., Electrical Systems Engineering, Wright State University

Senior project: A cascadable 4-bit ALU Slice (NMOS Technology)

Patents, Record of Invention, and Recognitions:

Temperature Compensation for Magneto rheological Fluid Dampers

Enhanced Electronic Bump stop Algorithm with Trim set Compensation for Vehicle Build Variation

Recipient of the THINKER award, Delphi Energy and Chassis, Delphi Corporation

Publications

Jundi, K. and Moon, D. "Monitoring Techniques For Risc Embedded Systems," National Aerospace and Electronics Conference 93, Vol. 1, May 1993.

Jundi, K., EL-Ali, T., Eloe, P. "Introduction To Neural Networks And Adaptive Filtering," National Aerospace and Electronics Conference 93, Vol. 2, May 1993.

Jundi, K., and Moon, D. "Real-Time Monitoring For Software Development And Testing," National Aerospace and Electronics Conference 92, Vol. 2, May 1992.

Jundi, K. and Siferd, R. "Sampled Data Analog Signal Processor," National Aerospace and Electronics Conference 90, Vol. 1, May 1990.

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