Develop test plans for prototypes and products under development for clinical trials with respect to regulations, standards, and company quality systems.
Devise Client testing approaches when existing methods and/or equipment are not appropriate by sourcing or creating new test equipment.
Use first principles, statistics, and Six Sigma concepts to develop robust test methods and analyze data.
Document work clearly, accurately, and with high quality following GDP.
Manage work as part of the overall team.
Establish experimental protocols, conduct experiments, analyze results, document the information, and present conclusions/recommendations to cross functional team.
Working knowledge of setting and operation of pulmonary and nasal device testing equipment, e.g. spray particle size analyzer, Copley Scientific Breathing Simulator, Next Generation Product Impactor.
Working knowledge of safe operations to interact with powder/nebulized particles/droplets.
Working knowledge of Good Documentation Practices.
Qualifications
B.S. with 3-5 years of experience, M.S. with 1-3, Ph.D. with 0-1 years of experience in Biomedical Engineering or related fields (combination of chemistry and biology preferred).
Additional Skills/Preferences
Ability to run equipment such as an ultra-high performance liquid chromatography system and optical measuring systems.
Familiarity with purchasing and procurement of supplies and materials for prototyping and testing.
Effective technical writing, verbal communication, and presentation skills.
Working knowledge of 3D CAD software, preferably SolidWorks.
Ability to wear respiratory protective equipment, as needed, to safely work in lab.
Experience with appropriate regulations (CRF 820.30, ISO 13485, ISO 14971, etc.).