Biomedical Device Expert Consultant Resume
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Resume of PNI Consultant
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  • Biomedical
  • Public Healthcare
  • Medical
  • Medical Device Manufacturing

This expert attended The George Washington University, Washington, D.C., and received a Masters of Public Health concentrating in International Public Health/Promotion.

This expert attended the University of Akron and received a B.S. in Mechanical Engineering.

Biomedical Device Expert Consultant Resume
 

This expert has experience with public healthcare, nonprofit or institutional health research program enterprises, and medical and health-related research grant development and management. Biomedical product and medical device development, biomedical device design reviews, and good manufacturing practice are also areas of expertise this consultant has.

This associate offers expertise specific to medical device auditing, medical device design practice, management of new medical device product development and marketing. Technology scouting, portfolio development, new product development, identifying, designing and developing new medical products are also specialties of this expert. This expert is also experienced in business planning, development, fund raising, project management and support for nongovernmental organizations, foundations, and institutions. Related experience involves this expert's work with public health, medical, and clinical programs.

Additional experience of this associate includes design, development of endoscopic surgical devices, product development, generation and control of product documentation. Further experience of this expert includes clinical testing procedure development, shielded needle product, FDA approval, and design control seminars. This associate offers expertise specific to sops, quality manuals for two manufacturers, and design and fabrication of prototype diagnostic electromechanical volatile organic compounds collection devices. This associate also has knowledge in noninvasive screening of lung cancer and communicable diseases.

Specialization of this expert includes design of products for less invasive surgery, hemodialysis, IV therapy, and respiratory care and diagnosis. Additional specialization of this expert includes technical assessment of extracorporeal ultraviolet phototherapy for treatment of autoimmune disease or transplant organs to reduce rejection, regulatory review and market analysis, legal case review with testimony given through deposition or court appearances, and UCT and CDC training workshops. This expert has knowledge in volatile organic compounds in breath as markers of lung cancer, and breath testing for the diagnosis of disease. Design and development planning, meeting design controls, government partnering, and opportunities for developing medical technologies are also areas of expertise this associate has. This expert also has experience in the safe medical device act, and technology assessment.

This expert is highly experienced in areas including laparoscopic minimally invasive surgery, viable neointima, electrolour, and achievement of long term vascular tolerance. Resectoscope electrode assembly with non-conductive bearing tube, plastic surgical staple, two-piece tissue fastener with coinable leg staple and retaining receiver and methodology are also areas of expertise this associate has. This expert has knowledge in method and apparatus for applying a fastener to tissue with a pair of hollow needles

Consultant, Kevin Kennedy Associates Inc.

Providing international public health consulting, medical research grant development and management, biomedical device development consulting, failure analysis, forensic engineering, expert witness and related services to a wide variety of clients.

 

Public Healthcare Consultant, Cape Town, South Africa

Created and managed projects or programs impacting public health, met country health goals, improved healthcare services. Improved or supported health management, program entrepreneurship, leadership and innovation among new or young health and medical professionals. Developed practical or appropriate nonprofit or institutional health research or program enterprises. Experience included research and analysis of situation, issues and problems (e.g., SWOT analysis), strategic planning and operational development and coordination, networking, institutional partnerships, or consortia development, training in securing grants, sponsorship prospecting and development, program or project planning (including enterprise planning and social marketing), grant proposal planning, team development, and budgeting assistance, assistance in contract negotiations, and project management and analytical support (including monitoring, evaluation and reporting).

 

Advisory Consultant, Research Development & Support Division, Faculty of Health Sciences, Stellenbosch University, Cape Town, South Africa

Developed, wrote and managed grants and contracts on medical or health-related research programs or projects with the goal of significantly expanding research grants, subcontracts and program funding from international sponsors, such as government agencies and foundations. Projects were aimed at epidemiology and clinical research in infectious diseases (tuberculosis and HIV/AIDS), psychiatric disorders, diabetes, and cancer. Developed a research strategic plan based on various funding mechanisms. Communicated grant opportunities to Faculty and Tygerberg Academic Hospital (TBH) researchers. Trained the Faculty/TBH staff in the preparation of grant or contract proposals. Identified and developed sponsors and collaborating partners for specific projects or programs. Developed alliances, partnerships or cooperative agreements with private organizations. In conjunction with Principal Investigators (PIs) developed program or project goals, objectives, plans, evaluation measures, timelines and budgets. Assisted PIs to prepare coherent and compelling grant proposals. Managed the grants awards to insure that they meet University and sponsor policies and procedures and reported financial status of each project to sponsor. Established a Research Grants Management Office (RGMO). Helped plan, budget, negotiate, develop and write numerous research grant applications, proposals, subcontracts, LOIs and Concept Papers for 20 Principal Investigators that were sent to 9 potential international and national sponsors during the contract period. Obtained grant awards or subcontracts worth over $5 million from U.S. NIH (subcontracts under CIPRA and PACTG programs), USAID, and foundations (Gates Foundation, Secure the Future and Rockefeller) during the contract period to be managed by the RGMO. Met U.S. government and University requirements for financial and administrative management of external research funds per external audits. Edited a weekly newsletter. Led training seminars on grant acquisition. Completed a benchmark study on Sponsored Program Offices and other Universities expanding the Research Division web page with useful and timely information for faculty researchers and staff. Helped plan and develop the Centre for Tuberculosis Research and Education (CENTRE) and the Children’s Infectious Diseases Clinical Research Unit (KIDCRU).

 

Consultant, Faculty of Health Sciences, Division of Research Development & Support, Stellenbosch University, Cape Town, South Africa

Assisted in developing and writing the first direct grant application to the U.S. National Institutes of Health by a unit of the University. The application resulted in a $75,000 planning grant award to the Faculty to establish a Centre for TB Research and Education with the mission of educating TB/HIV/AIDS researchers in clinical, operational and health care research. Conceived, developed and completed a special project on operational research concerning the effects of excessive alcohol use by patients on their DOTS tuberculosis treatment compliance.

 

Biomedical Engineering Consultant, Doylestown, PA

Medical Device Product Development, Risk analysis (FMEA, FTA and Root Cause Analysis), design analysis (FEA, simulation, computer modeling), rapid prototyping, product verification, material and stability testing, design validation (clinical research protocols, analysis and reporting), product documentation (DHF, DMR), process development (process validation, vendor selection and auditing), and product regulatory submissions (510(k), PMA, PDP). Documented research management procedures that meet the FDA Quality System Regulation and ISO 9000 standards for new medical device product planning and development as well as document and data control. Legal Expert Consulting including risk and design analysis of medical devices in tort or patent infringement cases. Testified by deposition or in court in numerous cases.

 

Director of Engineering, Cabot Medical Corporation

Managed new product identification, design, development, manufacturing implementation, documentation and sustaining engineering support of laparoscopic surgical and implant products.

 

Senior Engineer, Davis & Geck Division, American Cyanamid Corporation

Performed conceptual design and development of innovative instrumentation and products for less invasive surgery. Conducted feasibility analysis and studies in implantable bioabsorable bone plates, with initial preclinical testing of prototype units. Conducted technology assessment of implantable vascular access devices.

 

Manager of New Product Development, Critikon Division, Johnson & Johnson Corporation

Managed new product investigation and development, product improvements and extensions for sterile, single patient use devices for IV therapy.

 

Senior Engineer, Ethicon Division, Johnson & Johnson Corporation

Performed conceptual design and development of implantable wound closure fasteners and appliers. Investigated new product needs, conducted feasibility and user research studies, produced conceptual designs, fabricated prototypes and preclinically tested the devices.

 

Program Manager, V. Mueller Division, Baxter Healthcare

Managed development of new cystoscopic and resectoscopic instrumentation for urological surgery. Gained experience in the design of urological, endoscopic, and electrosurgical devices.

Managed the design and development of a wide variety of sophisticated endoscopic and less invasive surgical devices with initial annual sales exceeding $1.5 million.

Doubled the size and professional level of a product development department and introduced computer based systems that significantly improved the generation and control of product documentation.

Developed clinical testing procedures, analyzed results and submitted 510(k) for a proprietary shielded needle product, which received FDA approval in 57 days.

Conducted design control seminars at two medical device manufacturers.

Wrote SOPs and quality manuals for two manufacturers.

Designed and fabricated a series of 12 prototype diagnostic electromechanical volatile organic compounds collection devices now in clinical evaluation with application in the noninvasive screening of lung cancer and communicable diseases.

Designed and products for less invasive surgery, hemodialysis, IV therapy, respiratory care and diagnosis.

Performed technical assessment of extracoporeal utraviolet phototherapy for treatment of auto-immune disease or transplant organs to reduce rejection and describing the market opportunity for this technology.

Conducted regulatory review and market analysis of a carbon-14 urea breath test for H. pylori gastric infections.

Reviewed dozens of legal cases with testimony given through deposition or court appearance in nine cases.

Designed and produced the BioMedTek website - a source of news and resources for the biomedical engineering community.

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