Project Management, Senior Design Control & Risk Management Specialist

• Oct 2018 - Present

Project management, combination product risk management, design control, quality engineering, medical device risk assessment, design history file management, SOP development, and usability engineering file oversight • Project Lead/Manager who successfully executed development and life cycle management projects which have achieved FDA approval in 2021 • Implemented the Design Control and Risk Management processes into the management of the Lioresal Kit combination products. • Development of a device quality management system including procedures/polices to support commercial combination device programs. Show less

Manager, Design Control and Risk Management

• 2018 - Sep 2018

Manager, Design Control and Risk Management (2018)– Project management consultant, risk management, client audit preparation, lifecycle management and design history document drafting including risk management plans, design inputs/outputs documents, device description (ISO Annex C) and design failure mode analysis (dFMEA) • Attained 100 percent client retention through effective-execution of project management and strategic planning support to ensure deliverables exceeded client expectations • Achieved a rate of zero (0) major non-conformances and zero (0) significant audit findings for client(s) with assiduous lifecycle risk assessments and design history documentation • Ensured preparedness for 510k pre-submissions and submissions through management of all technical aspects for client projects • Developed design control documentation, as a member of the technical team; maintaining concise design history files (DHF) for audits and regulatory filings Show less

Manager, Design Control and Risk Management

• 2017 - 2018

Manager, Design Control and Risk Management (2017-2018) –Risk management and project management, audit preparation, lifecycle management, technical writing and manager of effective and exhaustive design history file(s) (DHF) • Reaching a 25 percent reduction in project delays using industrious assessment of products throughout the project lifecycle; supporting multiple-product(s) • Reduced the organization’s existing procedures by 85 percent, resulting in significant budget savings in both the quality assurance and the design control and risk management departments • Assessment and generation of continually-changing risk management and product related best-in-class: documentation, procedures and standards; ensuring effective and efficient processes Show less

Research Scientist

• 2005 - 2017

Research Scientist (2006-2017) – Subject matter expert (SME) in method development and biocompatibility, for product research and development, regulatory affairs, marketing and product claims• Conducted research at Los Alamos National Laboratory in a collaboration to assess biological-structural reactions to external stimuli using the Particle Accelerator Neutron Reflectivity Technology (SPEAR)• Nominated and served on the Research and Development’s ideation team, a next generation research and innovation team (1 of 15 members selected for this role, reporting directly to the Head of Research and Development)• Developed novel methods for in vitro and ex vivo screening of new product materials and coatings, attaining national and international publications (4) and presentations (18)Research Associate (2005-2006) – Development of novel methods for material and coating assessments, to support products from ideation to implementation, to assess silicone hydrogel biomaterial, coating, and biomimetic characteristics Show less

Member Board Of Directors

• 2014 - 2016