Biomedical Engineer

Job Description :

Pay Range: $70.51hr - $74.51hr

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 overall team.
• Experience in establishing experimental protocols, conducting experiments, analyzing results, documenting the information and presenting conclusions/recommendations to cross functional team.

• The Drug Delivery and New Product Innovation team in Boston explores and applies new technical solutions across delivery systems, with focus in the following areas:
• Drug delivery of new therapeutic modalities.
• Mechanical and electromechanical devices and test systems.
• Injection/infusion fluidic control systems.
• Fundamental understanding of the interplay of the device, anatomy and physiology
• We are seeking a highly motivated, skilled, and creative scientist or engineering professional to join our team to support the test and evaluation of formulations and prototypes.
• If candidates wish to grow candidates scientific and engineering knowledge to push technical frontiers to build breakthrough solutions for patients and physicians, candidates should consider joining our diverse 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 Cascade Impactor.
• Working knowledge of safe operations to interact 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 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.
• Strong communication skills and the ability to be an inclusive colleague in a highly interdisciplinary environment.
• Upkeep of a clean and
  *** lab space.
• Familiarity with purchasing and procurement with 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.).