Project manager / engineer

RESUME

Nancy Casteel

***** *. ********* ****** *****: 708/ 805-6233

Ingleside, Illinois 60041 ********@*****.***

Career Summary: Senior engineering manager and scientist, most recently employed for ten years in the medical device industry as a Systems Validation Manager and as a Software Validation Quality Assurance Engineer (ASQ-CSQE). Former experience includes five years in industry as a food chemist and as Director of a Quality Control lab and experience as a senior scientist, educator and researcher in the biomedical research field.

Professional Experience in Industry:

Validation Remediation Specialist (contractor, Natus\Mundelein, 4/11- current position) DHF Remediation of hardware, firmware and data processing software for legacy hearing testing devices. Assessment and reconstruction of systems requirements, testing, and documentation to comply with EN 14971:2009 Application of Risk Management to Medical Devices.

Quality Assurance Engineer (contractor, GE Healthcare, 11/01/10 – 12/30/10) Short-term (1 month) contract position to provide technical and documentation review of validation documentation for 510k submission. Extended additional month to assist in SOP development.

Manager I, V&V Engineering (employee, Fenwal, 3/07 – 7/10). Manager of Verification and Validation activities for the ALYX and Auto-C blood apheresis instruments. Led team of 8-23 software and systems engineers including permanent Fenwal employees, outside contractors and consultants, and personnel at an off-shore testing facility in India. Directed systems and software verification and validation testing, tracing of requirements to testing, design specifications, FMEA and Risk Management plans. Documentation of compliance to life cycle, FDA and TUV standards. New product development and sustaining engineering projects. Root Cause Analysis and problem resolution. General project management responsibilities (deadlines, resources, budget) and project documentation (V&V Plan, Requirements Trace Matrix (RTM) and Report). Implemented risk-based approach to testing.

Principal Engineer and Systems Validation Lead (employee, Baxter International/ Transfusion Therapies division, 4/06-2/07- Note: division sold, became Fenwal, Inc., see above). Coordinated activities of five engineers for complete systems validation cycle (SDLC) for international release and maintenance of medical device. Authored, updated and executed test protocols for imbedded software releases and updates. Authored validation plans and reports. Evaluated test failures for root cause of failures and for business and/or compliance risk; recorded and resolved issues. RequisitePro and DOORS tools utilized primarily.

Principal Engineer (contractor, Baxter International 1/05-3/06). Systems analysis and testing of a blood collection medical device, for verification and validation of hardware and software. Updated test methods/ protocols to test system against design requirements. Monitored compliance to Risk assessment. Generated requirements trace matrices and test plans. Executed test protocols and generated requirements trace matrices and test reports.

Software Quality Engineer (contractor, Abbott Diagnostics Division, 5/2004-11/2004). Quality audit of validations of large legacy software applications that have been assessed as high or critical priority, to determine level of FDA compliance to acceptable SDLC practices and 21 CFR Part 11 requirements for medical devices. Reported needed remediation to project teams and management.

Software Quality Assurance Engineer (contractor , Abbott Laboratories, 1/2002-12/2003).

Assessed divisional procedures to determine compliance with ISO 12207. Authored Software Development Life Cycle SOPs to improve compliance and participated as SQAE in pilot project to assess effectiveness. Concentrated on improving Risk Assessment, Change Control, and Problem Reporting procedures. Developed training to improve verification practices.

Validation Quality Engineer (contractor, Abbott Laboratories, 4/2000-12/2001).

Final Quality sign-off responsibility for validation of large software projects demonstrating that they are compliant with corporate and site Operational procedures, compliant with government regulations for medical devices (FDA 21 CFR Part 11 and part 820) and that they have met their User Requirements and Functional Specifications. Approval of IQ/OQ/PQs and other SCLC and validation documentation. CAPA system, labeling systems, data warehouse, LIMS systems, mainframe manufacturing systems, Documentum and MES.

Assistant/ Associate Professor of Microbiology and Immunology, Research Director, Neuroimmunology Laboratory, teaching and training responsibilities, 34 publications – multiple locations: University of Southern California, Midwestern University, University of Chicago (Non-industry experience).

Food Chemist (Henri’s Foods; Penick and Ford, Ltd)

Director of Quality Control and Quality Assurance for line of salad dressings produced by Henri’s Foods. Determined that outside quality control laboratory had previously been reporting fraudulent results. Organized and supervised in-house quality control laboratory. Established SOPs, Quality Assurance reporting protocols, wrote product labels to conform to government standards.

Chemist, Customer Service Department. Product analysis and problem solving of customer’s products produced using con syrup produced by Penick and Ford, Ltd. Performed laboratory analyses and authored reports. Production quality control, including microbial analysis of water effluent.

Training:

Ph.D. UHS/ Chicago Medical School, Biochemistry, Immunology

M.S. Medical College of Wisconsin, Biochemistry, Immunology

American Society for Quality - ASQ-CSQE (2002)

American Medical Writers Association (AMWA) – Certification in Pharmaceutical Writing

Computer Coursework, College of DuPage and elsewhere - Classes in general programming, database management, systems design, web programming, and project management

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