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. • 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. 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.