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James Nelson resume

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James Nelson resume

  1. 1. James R. Nelson, MBA Cell: (520)-270-9205 E-mail: janelson@email.arizona.edu Manager with over 25 years of experience in Medical Device Industry including Project Management, Business Development, Sales and Marketing. Demonstrated leadership in working with cross-functional project teams to execute and achieve business targets/goals. Innovative and forward thinking with strong interpersonal skills. Key Competencies Research and Development Sales Management Project Management (concept to launch) Customer and Public Relations Regulatory - FDA Submissions Cancer Diagnostics Cardiovascular Medical Devices Start-up Environment Education Master of Business Administration December 2002 University of Phoenix – Tucson, AZ Bachelor of Science in Public Administration December 1996 University of Arizona – Tucson, AZ Professional Experience Project Leader, R&D Xeridiem – Tucson, AZ August 2011 – July 2014 • Managed multi-discipline projects implementing phase gate processes • Worked closely with Business Development Directors to achieve accurate quotes • Coordinated timelines/budgets for complex projects • Managed customers to meet expectations/targets/goals • Increased project revenue over 50% from existing business equating to over $2M • Trained/supervised manufacturing floor for improved product builds • Led project leaders to achieve most efficient use of allocated resources Project Manager, R&D August 2010 – June 2011 Ventana Medical Systems, Inc – (Division of Roche Tissue Diagnostics) Tucson, AZ • Managed multi-discipline projects to support cross-functional teams for executive decisions • Successful in obtaining Pre Market Approval (PMA) from Food and Drug Administration (FDA) for complex projects • Managed Immuno Histo Chemistry (IHC), Insitu hybridization (ISH) molecular probes and antibody projects • Coordinated timelines/budgets for complex projects (>500K) • Guided teams through Product Development Process to ensure consistency and optimization • Consistent communications with stakeholders, including compiling and reporting of high profile projects
  2. 2. • Coordinated strategic planning sessions to achieve optimal outcomes Biopsy Sciences LLC – Tucson, AZ Director of Clinical Specialties 2008 - 2010 Project Manager 2005 - 2008 Research Associate 2001 - 2005 • Managed multi-center randomized clinical trial, pending 510(k) FDA approval • Launched “HydroMARK” breast biopsy site marker in 25 states from concept to launch with over $1M sales annually • Contacted clinicians/customers and maintained accounts • Participated in design and development and new product development meetings • Directed all functions related to pre-clinical research for the development of cutting edge biopsy and oncology product lines • Managed and motivated employees to perform surgeries, tests and experiments related to product design, development, submission and FDA approval • Worked with Quality Assurance and Regulatory Consultants to develop the company’s Quality Manual, Product Design History File (DHF) and Instructions for Use (IFU) for 510(k) and Investigational Device Exemptions (IDE) submissions Project Manager 2000 - 2002 Harmonia Medical Technologies - Tucson, AZ • Directed and managed functions related to pre-clinical research for the development of surgical and less invasive urological products • Coordinated and performed surgeries, tests, and experiments. Worked directly with project engineering for product development, advancement and improvement • Wrote pre-clinical protocols and final reports concerning study design, development and outcomes • Composed laboratory Standard Operating Procedures (SOPs) and maintained laboratory Good Laboratory Practice (GLP) status • Developed biodegradable polymer for urethral patency post transurethral resection of the prostate (TURP) Clinical Research Associate 1998 - 2000 AngioTrax, Inc- Sunnyvale, CA • Planned and guided off-site and in-house research projects, experiments, and testing in university and hospital settings • Coordinated, monitored, and reported device performance under simulated and actual use conditions • Worked directly with project engineers toward product development, performance and improvement • Planned, developed, and performed studies for FDA submission and approval • Wrote pre-clinical GLP and non-GLP study protocols and reports • Implemented laboratory SOPs and maintained laboratory GLP status • Developed transmyocardial revascularization device to treat ischemic heart disease
  3. 3. Research Specialist 1986 - 1998 University of Arizona- Tucson, AZ • Performed cardiac studies that changed Advanced Cardiac Life Support (ACLS) national standards • Planned, scheduled, performed and implemented surgeries, tests and experiments within a university setting • Worked closely with private businesses testing and improving new medical devices • Coordinated and performed experiments to study effects of interactions between cardiac medications and implantable medical devices • Operated and monitored complex implanted medical devices during pre-clinical experiments including collecting, analyzing and reporting data • Supervised and managed staff in a laboratory setting • Responsible for laboratory finances and all controlled substances/narcotics • Assisted with writing grant proposals • Developed new CPR techniques influencing national standards Visiting Research Scientist • Rush Presbyterian St. Luke’s Medical Center, Chicago, IL. – 1999: Percutaneous Myocardial Channeling Device Evaluation and GLP Monitor. • Ohio State University, Columbus, OH – 1993: Manual CPR vs. the Thumper, a CPR Device. • Purdue University, South Bend, IN – 1988: The Effects of CPR with Sustained Ventricular Fibrillation.

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