Engineer

Position 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

Quals--
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 you wish to grow your scientific and engineering knowledge to push technical frontiers to build breakthrough solutions for patients and physicians, you should consider joining our diverse team.
Minimum Requirements:
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 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)
Attendance 5 days/week on-site for lab work
Additional Skills/Preferences:
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 healthy 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 SolidWorks
Ability to wear respiratory protective equipment, as needed, to safely work in lab
Experience with appropriate regulations (CRF 820.30, ISO13485, ISO 14971, etc.)
Other Information:
Location: Boston Seaport, MA.
Client is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.