SUMMARY - Clover Sites
SUMMARYOver 16 years in medical device product developmentOver 10 years as a technical manager responsible for hardware/software verification and validation of medical devicesAuthored design control documentation and implemented full life-cycle design control activities for over 50 medical device product releasesAuthored content for over ten 510(k) submission packagesEstablished design history files for over 50 product releases and successfully presented details of their compliance in over ten auditsAuthored a full range of operationally practical, FDA and ISO compliant quality systems procedures and associated documentation templatesInternational experience supporting outside US companies in establishing FDA compliance for US product releasesFive years experience instructing computer science classes at the junior college level CONSULTINGConsultant to major companies in the medical device, diagnostics and diagnostic instrumentation industries. Range of consulting services provided includes the authoring of 510(k) submission packages, the authoring of risk management and technical design control documentation, the authoring of FDA and ISO compliant quality systems procedures, ISO 13485, ISO 14971 and IEC 62304 compliance audits and gap analysis reports, and guidance in implementing best practices. Vertical markets supported include critical care and homecare ventilation, MRI image processing applications, CT image processing applications, interventional radiological procedure instrument guidance, IVD diagnostics and diagnostic instrumentation devices. Consulting style integrates extensive technical and managerial product development experience with practical, proven practices in establishing compliance with FDA and ISO regulations. DESIGN AND VALIDATION EXPERIENCEOver 30 years overall product development experience in a variety of technical and technical management roles. Initial career experience in software engineering with specialization in the development of test automation tools. Career advancements led to leadership roles establishing standardized software development life-cycle processes and implementing formal independent test engineering groups throughout those life-cycles. Career focus the last 16 years in product development for Fortune 500 medical device companies. Primary responsibilities during this period include all aspects of hardware/software verification and validation testing for complex life support devices. These responsibilities included the establishment of quality systems procedures and all associated design control documentation required to establish FDA compliance. Track record of 100% positive outcome from FDA reviews and audits of design control deliverables provided for over ten 510(k) submissions and design history files for over 50 new and enhancement product releases. FDA SUBMISSIONSFluent in preparing 510(k) submissions and associated supporting documentation. Expert at preparing submission packages that result in reduced review times and successful clearances . Have provided 510(k) packages to the FDA for a wide range of medical devices from critical and homecare ventilator products, orthopedic hardware/software systems, IVDs and interventional radiology interventional instrument guidance devices.. AUDITORExpert at audits for compliance with FDA regulations and ISO standards. Audit style centers on ensuring full organizational clarity of potential compliance exposures and providing practical recommendations for addressing root cause. Audit feedback and recommendations based upon practical career experience that resulted in successful outcomes from numerous FDA and third party internal audits for life support devices that are held to extreme levels of compliance scrutiny. SOFTWARE DEVELOPMENT EXPERIENCEExtensive experience in software development organizations with specialization in establishing standard software development life-cycle processes and the integration of formal, independent test groups into those cycles life-cycles. Product experience ranges from real-time imbedded medical device software, clinical information systems, and a variety of specialized software development areas ranging from operating systems, communications, and client-server applications.INSTRUCTORHold lifetime California Junior College teaching credential and been an instructor for computer science classes at the junior college level for five years. Have instructed courses in a variety of programming languages and systems analysis and design.EDUCATION SYMBOL 183 \f "Symbol" \s 10 \hMS/Systems Management, University of Southern California 1982SYMBOL 183 \f "Symbol" \s 10 \hBS/Information Systems, University of Arizona, 1979 ................
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