Al K.

I am available for short- or long-term contracts for performing Medical Device Risk Management: FMEA, Risk Analysis, Requirement/Risk/Testing Trace Matrices, and Requirement Authoring.

Organized first meeting and served on ad hoc board until volunteering for and being elected Vice President.

Participated in Board of Directors meetings; performed administrative work as necessary to support the Chicagoland Chapter.

Coordinated member recruitment and retention activities for the Chicagoland Chapter.

Supported the board's activities, led meetings in the absence of the President, and performed various tasks necessary in the running of the Chicagoland Chapter.

Complaint Investigator per 21 CFR 820.198 and CAPA author per 21 CFR 820.100. Performing monthly Complaint Trending Reports. Assisting with Alinity m Risk Management File updates and complaint risk analyses. I am a Certified Alinity m Field Service Engineer: installing, repairing, and maintaining in-house instruments.

Authored Risk Management File for the Alinity m automated PCR testing device (Risk Management Plan, Failure Mode and Effects Analysis, Risk Analysis, Use Error Failure Mode and Effects Analysis). Sole author of Alinity m Software FMEA and Risk Analysis, per IEC 62304. Assisted authoring Alinity m Software Requirements and Product Requirements.

As a member of Software Development department, I collected customer and marketing requirements for five pharmacy automation product lines. From them, I authored and managed requirement, specification, interface, and design documents for electronic hardware subsystems, computers, and peripherals used in pharmaceutical dispensing and packaging systems. I selected components (servers, computers, peripherals, electronic components, etc.) for four products lines and was the primary contact with suppliers. I managed design changes and approved component substitutions to circuit boards being assembled by third party manufacturers. As a member of the OptiFill Controls Engineering Team, I documented the site-specific and common specifications for large central-fill pharmacy systems, and was a member of new installation and field upgrade teams.

I was a member of a team of Systems, Mechanical, and Software engineers working on a new Digital Pathology System that worked with the cytology slides produced by the company's MonoPrep instrument. The Digital Pathology System scanned the slides, identified cells that are likely to be cancerous using pattern recognition with Artificial Intelligence, and presented these images to a Cytologist for diagnosis. I was the author of the Risk Management File (Failure Mode and Effects Analysis, Hazard Analysis, Risk Analysis, and Fault Tree Analyses), co-authored the System Functional Requirements, and authored the Requirement Traceability Matrix. Alas, due to the financial crisis, MonoGen was unable to secure working capital and ceased to exist on December 30, 2008.

Ported requirements from Requisite Pro to DOORS, including setting up all tracing between high- and low-level requirements. Led Systems Engineering team for one phase of a software release for a blood separation instrument (separating blood cells and plasma). Re-wrote existing plasma separator requirements to meet modern standards and ported into DOORS. Authored and traced new release plasma separator requirements for software, hardware, mechanical, and disposables.

Systems and software engineering: interfaced with customers, negotiated and authored requirements, coded, integrated, and tested software, tested and configured hardware, and maintained/delivered software updates to systems in the field. I managed a team of four local and two remote hardware and software developers.

Documentation Tools Developer: interfaced with customers (Technical Writers and Technical Writers' Managers), negotiated and authored requirements, coded, integrated, and tested software, authored user documentation, and performed technical/customer support.

Many positions... Standards Group (authored company-wide standards documents and managed standards document source control), System Performance Measurement System - QUARTZ (led a team of four engineers, authored requirements, developed code, and tested hardware and software), Storage Group (authored and maintained Unix drivers for several SCSI storage devices on several AT&T hardware platforms), 5ESS(c) International Switching System - Systems Engineering (interfaced with international customers, negotiated and authored requirements documents, responded to RFPs, authored and was critical reviewer of technical specifications, represented Operations, Administration, and Maintenance (OA&M) group at weekly Modification Request (MR) meetings, and coordinated OA&M MRs).

Masters Thesis: Digital Artificial Reverberation for the UIUC Computer Music Project; Thesis advisor: James W. Beauchamp Research Assistant, Computer Music Project: designed, developed, and tested a Graphical User Interface for the Computer Music Laboratory Individual research project: numerical analysis of and enhancements to a PhD thesis 3-D image processing algorithm for professor Thomas S. Huang

Individual research project: computer graphics system trackball interface for Professors Tom Defanti and Dan Sandin