Experience:

DeJarnette Research Systems, Inc., Towson, MD.
May 1994 to present

Regulatory / Quality Assurance Officer.

Responsible for Quality Assurance, documenting and enforcing corporate Standard Operating Procedures and implementing Good Manufacturing Practices (GMP) for Medical Devices, addressing FDA and other regulatory issues, and records retention. Beginning implementation of the new Quality System Regulations (QSR) issued by the U.S. FDA. Versed in U.S. FDA GMP, QSR, EU Medical Device Directive and the ISO 9000 Series. Part of team responsible for filing 510(k)s for three (3) DeJarnette medical devices, which were evaluated and approved within 60 days of filing. Established the DeJarnette Quality System, based on the ISO 9000 Quality System, and maintains all processes required to support the Quality System. Implementing the ISO Standard in a small computer software and equipment manufacturing corporation.

Software Engineer.

Software Engineer. Worked on the Imageshare 910 Film Digitizer Acquisition Station, Imageshare 1000 Film Digitizer Acquisition Station and Video Acquisition Station lines of products. Added new features, redesigned user-interface, technical support, and full documentation from test plans to system manuals and user documentation. Porting Imageshare line of products to OS/2. Redesign and development of new user interfaces and acquisition module for the Imageshare 1000. Worked on various other projects from updating the Teleshare 910 (a low-end teleradiology display station) to various other teleradiology communications products, Imageshare 910, DICOM/IPC, DICOM/RTV and various product user interfaces. Documentation control and updates, UNIX System Administration.

Westinghouse Electric Corp., Electronic Systems Group, Linthicum, MD.
Sept 1991 to May 1994

Associate Engineer, Air Traffic Control.

Design and implement Data Reduction and Analysis for the Moroccan Air Traffic Control System. Design off-line system that reads and analyzes recorded Radar Data, and implement the mechanism that transfers the data between VAX VMS and ULTRIX system, translates the data, and outputs the information over a local area network.

Member of the MSSR - Moroccan Air Traffic Control System team developing an embedded real-time system software package that tracks aircraft using information from multiple radar systems. Participate in design and development of the tracker subsystem in DEC VAX/VMS environment.

Participated in the development of the Interim Beacon Initiative for the Mode-S Air Traffic Control system. Perform system engineering work, including programming and debugging embedded system software in C, UNIX script programming, burning PROMs and testing software systems. UNIX System administrator for the Gould 6000 on which the Mode-S software is developed. Involved in software documentation and the design of software engineering tools to aid in documentation.

United States Department Of Energy, New York, NY
Sept 1989 to Aug 1991

Engineering Consultant (Part-time).

Supervisor of group responsible for engineering analyses of Federal Grant Applications for the U.S. Department of Energy's Institutional Conservation Program. Assisted PC network supervisor in daily procedures. Performed PC software troubleshooting and training of personnel in the use of the software.

Securities Industry Automation Corp., New York, NY
Jan 1989 to Aug 1989

Programmer/Analyst, Regulatory & Administration.

Co-op position. SIAC is the technological arm of the NYSE. Involved analyzing the system of recording time sheets for the R & A department in order to automate the process. Designed and developed a PC implementation of the mainframe payroll entry system using Paradox 3.0. Participated in various programming projects to aid administration.

Education:

Polytechnic University, Brooklyn, New York 11201

M.S. Computer Science, June 1991. (Software Engineering)
B.S. Operations Research, January 1991. (Manufacturing)

Stat-A-Matrix Workshop:

EU Medical Device Directive (18-19 February 1997) . Conducted by Stat-A-Matrix.

FDA Medical Device Workshops:

Regulatory Requirements for Medical Devices (30 April 1996), Good Manufacturing Practices (1 May 1996), Medical Device Reporting (2 May 1996). Conducted by DSMA, and the U.S. F.D.A. Northeast Regional Office.

ISO 9000 Implementation:

3.6 CEU, 5-9 February 1996. Conducted by Perry Johnson, Inc.

FDA Medical Device GMP Workshop:

Good Manufacturing Practices (1 June 1995). Conducted by DSMA, and the U.S. F.D.A. CDRH Office of Compliance.

Professional Societies:

R.A.P.S. - Regulatory Affairs Professionals Society

ASQC - American Society for Quality Control

Skills:

Regulatory:

Versed in U.S. FDA QSR and GMP, EU Medical Device Directive and ISO 9000 Standard. Implementing FDA GMP and QSR and have begun work towards ISO 9000 certification. Familiar with EU EMD and Low Voltage Directive, and Canadian Medical Devices Regulation.

Quality Assurance:

Experience in implementing corporate Quality Policy. Involves applying standard industry quality practices to a small corporate environment. Includes process documentation, recording standard operating procedures, documentation control. Versed in ISO 9000 Standard. Implementing FDA QSR and have begun work towards ISO 9000 certification.

Manufacturing:

Relevant university coursework includes requirements for the M.S. Manufacturing Degree. Senior Project: Applied Manufacturing/Computing Techniques. Experienced on small assembly line: assembling, testing, and shipping computer equipment. Experienced in documenting manufacturing process and implementing U.S. FDA GMP (Good Manufacturing Practices) - design, labeling, process control and documentation.

Training:

Training personnel on systems ranging from word-processing to personal computers.

Web Page Design:

Proficient in HTML, currently managing the DeJarnette web server. Has own web page, (http:\\www.charm.net\~efinegan), as well as developed and supporting the PACSpage: Telemedicine / PACS Resource Page (http:\\www.charm.net\~efinegan\pacspage.html).

Software Engineering:

Proficient in C, C++, UNIX C shell script, and Pascal. Database programming, primarily Paradox V3.0. Working knowledge of HTML, X-windows, BASIC, and CMS Exec Batch. Understanding of software architecture and design, assembly language, Ada, user interface development, and software engineering techniques.

Operating Systems:

Proficient in UNIX (including system administration, SunOS, Solaris, DEC UNIX), OS/2, MS-DOS, Microsoft 95, Microsoft Windows 3.x and VAX/VMS. Experience with Novell networks, System 7, and CMS systems.

Software:

Experienced with various business, communications and software development packages, notably Microsoft Office, Microsoft Word (5.0 - 95), Inmark zApp, Microsoft Excel, Paradox 3.0, Lotus 1-2-3, WordPerfect 5.1, Dbase III Plus. Hands on experience with many other packages.

Documentation:

Involved in technical writing and documentation control. Preparing documentation for various departments: Quality Assurance, Manufacturing, Materials Handling, Software Design, Software Testing, User Manuals, Service Manuals, Technical References, and Marketing Literature.

Keywords: (for search) Resume,Software,Engineer,Medical,Device,Telemedicine,Teleradiology,Radiology,PACS,Quality,Regulatory

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