Biomedical Engineer

Responsibilities

• 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.

• 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).

• 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 Solid Works.
• 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.).