Summary: Ph.D.-level Biomaterial Scientist with unique combination of business, program management and technical knowledge and medical device experience, strong academic credentials in cardiovascular biology/chemistry, biomedical engineering and new product/process development Skills: • Program Manager with in depth knowledge and preclinical research and feasibility studies of medical devices, with experience in risk management, complaint handling, program management and CAPA programs and product/process development experience of > 25 years in academic and industrial institutions. • Working knowledge on biomaterials, proteins, polymers, metals, ceramics, surface modifications, tissue engineering, drug delivery and cardiovascular devices. • Expert in transdermal drug delivery, oral, inhaler tests, site specific drug delivery and protein encapsulation in a GMP regulated environment. • Working knowledge on left ventricular pressure sensor, ECG monitoring implants for heart failure treatments, pericardial tissue processing for heart valve applications, polymeric coatings for preventing thrombosis, implantable hemostats, bone wax for bone bleeding and regeneration, infection prevention and combination process development. • Experienced with films, microspheres, micro tubes, vascular grafts, biosensors, vascular stents, catheters, tissue based materials and small animal implantation. • Demonstrated capability of thinking creatively with knowledge of cardiovascular systems, & interventional cardiology and vascular/neuro products. • Knowledge of Medical, FDA and ISO 13485 standards and experience relating to EN 22442-1, -2, -3 Medical devices utilizing animal tissues and their derivatives and ISO 14971 Medical device-Application of risk management. • Capable in writing pre-clinical, clinical, FDA study reports and presenting to key opinion leaders. • Uses Minitab statistical methods for test method validation and design of experiment (DOE) tools to effectively analyze test results and document them. • Knowledge of catheter development, flow rates, fluid dynamics and catheter evaluation using pumps and analysis of data. • Familiar with new test method developing as needed to assess product strength, long-term stability, safety and biocompatibility (ISO 10993). Managed DV testing of combination devices. • Strong communication and program management skills, team work skills, organizational skills and ability to work in a multi-cultural environment... • Reviewer to several international journals and international project funding agencies. Education: • Postdoctoral Fellowship, Cardiovascular implants. Biomedical Engineering Institute, University of Minnesota, 1997-1999. • PhD Biomaterial Science and Technology, Sree Chitra Institute, India, 1988. • MS Biochemistry major, Kerala University, India. • BS Chemistry, Kerala University, India. Work Experience: From 2014 March Onwards: Sr. Test Engineer, Phillips-Medisize, Hudson, WI Manage, project lead and develop test protocols and use them for evaluating inhalation (lung) drug delivery devices. Test Lead and Manager for projects, insulin inhalers, wearable injectors and drug delivery devices for DV testing and product development support. From 2011 Jan to 2014Jan: Lead Research Material Scientist and Program Director, HemostasisLLC, St. Paul, MN Project lead/Manager for developing hemostasis microspheres, tissue sealants and novel bone wax products and manufacturing technologies. Directly managed several projects and developed starch based hemostats. This included project schedule, technology development, validation, transfer to manufacturing and preclinical testing. Led technical writing of reports and helped with CE marking. From 2009 November to 2010 May: Formulation Scientist, Drug Delivery Division, 3M Company, St. Paul, MN. Research and development of novel protein formulations and micro-needle transdermal drug delivery studies on porcine transdermal models. Worked with novel protein formulations and coating them on solid microneedles for transdermal delivery. The work also involved protein stability studies and microscopic evaluations. From 2009 July to 2009 November: Research Associate, Cardiovascular Division, University of Minnesota, MN 55455. Research and technology development on implantable interventional cardiology devices for patient care. Project lead for nanotechnology and tissue engineering principles for new product development for preventing thrombosis and clot removal technology. The project emphasized on oral delivery of biomolecules such as LMWHep, hirudin or proteins for pharmaceutical applications. From 2004 to August 2008. Sr. Materials Engineer, Mechanical Engineering Group, Transoma Medical, 119, 14th St. NW, St. Paul, MN 55112, USA. • A medical device company involved in establishing implantable monitoring as a standard for guiding therapeutic interventions in human health care (for advanced heart failure