Join the Drug Delivery & New Product Innovation team to support testing and evaluation of drug delivery formulations, devices, and prototypes for pulmonary and nasal applications.
Responsibilities:
Develop and execute test plans for prototype and clinical-trial products. Perform experimental testing, data analysis, and technical documentation. Design or source novel test methods and equipment when needed. Apply statistical and Six Sigma principles to test development. Present findings and recommendations to cross-functional teams. Maintain compliance with quality systems and Good Documentation Practices (GDP).
Requirements:
B.S. with 3-5 years'''' experience (or M.S. with 1-3 years, Ph.D. with 0-1 years) in Biomedical Engineering or related field. Hands-on experience with pulmonary/nasal testing equipment (e.g., NGI, breathing simulators, particle size analyzers). Knowledge of safe handling of powders, aerosols, and nebulized particles. Experience with experimental protocols, testing, data analysis, and reporting. Ability to work onsite 5 days/week in Boston, MA.
Preferred Skills:
Experience with UPLC, optical measurement systems, and SolidWorks. Familiarity with
ISO 13485, ISO
14971, and 21 CFR 820.30. Strong technical writing, communication, and teamwork skills. Experience with lab operations, procurement, and prototyping activities.