Cambridge, MA 02142 US
• Working knowledge of setting and operation of tensile and torque testing machines, preferably plastics and tissue using Zwick/Roell tensile testing • Working knowledge of Good Documentation Practices • Working knowledge of 3D CAD software, preferably Solid Works • B.S. with 3-5 years of experience, M.S. with 1-3 years of experience in Mechanical, Materials or Biomedical Engineering or related fields (combination of mechanical and biological preferred)• Ability to run equipment such as digital microscopes, 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 • Experience with appropriate regulations (CRF 820.30, ISO13485, ISO 14971, etc.)
The Drug Delivery and New Product Innovation team in Cambridge 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 fluid control systems • Fundamental understanding of the interplay of the device, anatomy and physiology We are seeking a highly motivated, skilled, and creative engineering professional to join our team to support the test and evaluation of materials and prototypes. If you wish to grow your engineering knowledge to push technical frontiers to build breakthrough solutions for patients and physicians, you should consider joining our diverse team.
Position Responsibilities: • Develop test plans for prototypes and products under development for clinical trials with respect to regulations, standards, and company quality systems • Devise novel testing approaches when existing methods and/or equipment are not appropriate by sourcing or creating new test equipment • Use engineering first principles, statistics, and Six Sigma concepts to develop robust test methods • Document work clearly, accurately, and with high quality• 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