Biomedical Engineer

Qualifications

The Drug Delivery and New Product Innovation team in Boston focuses on exploring and applying innovative technical solutions across drug delivery systems. Core areas of focus include:

• Drug delivery for new therapeutic modalities
• Mechanical and electromechanical devices and test systems
• Injection and infusion fluidic control systems
• Fundamental understanding of the interaction between device design, anatomy, and physiology

We are seeking a highly motivated, skilled, and creative scientist or engineering professional to support the testing and evaluation of formulations and prototypes. This role offers an opportunity to expand scientific and engineering expertise while contributing to breakthrough solutions for patients and physicians within a diverse, collaborative team.

Minimum Requirements

• Working knowledge of setup and operation of pulmonary and nasal device testing equipment, such as spray particle size analyzers, Copley Scientific Breathing Simulators, and Next Generation Cascade Impactors
• Working knowledge of safe handling and operation involving powder and nebulized particles or droplets
• Familiarity with Good Documentation Practices (GDP)
• Educational background and experience requirements:
• B.S. with 3–5 years of experience
• M.S. with 1–3 years of experience
• Ph.D. with 0–1 years of experience
• Degree in Biomedical Engineering or a related field (combination of chemistry and biology preferred)
• Ability to work on-site five days per week to support laboratory activities

Additional Skills and Preferences

• Ability to operate ultra-high performance liquid chromatography (UHPLC) systems and optical measurement systems
• Strong communication skills and the ability to collaborate effectively in a highly interdisciplinary environment
• Commitment to maintaining a clean, safe, and well-organized laboratory space
• Familiarity with purchasing and procurement of supplies and materials for prototyping and testing
• Strong technical writing, verbal communication, and presentation skills
• Working knowledge of 3D CAD software, preferably SolidWorks
• Ability to wear respiratory protective equipment as required for safe laboratory work
• Experience with relevant regulations and standards (e.g., CFR 820.30, ISO 13485, ISO 14971)

Responsibilities

• Develop test plans for prototypes and products intended for clinical trials in alignment with regulations, standards, and company quality systems
• Design and implement novel testing approaches when existing methods or equipment are insufficient, including sourcing or creating new test equipment
• Apply first principles, statistical methods, and Six Sigma concepts to develop robust test methods and analyze data
• Clearly and accurately document work in compliance with Good Documentation Practices
• Manage assigned work as part of an integrated team environment
• Establish experimental protocols, conduct experiments, analyze results, and document findings
• Present conclusions and recommendations to cross-functional teams