Associate Director, Device Development

Role: Associate Director, Device Development, leading the end-to-end development and lifecycle management of drug–device combination products, primarily injectable systems like prefilled syringes and auto-injectors. Responsibilities include defining and executing device strategies, translating user needs into product requirements, leading human factors activities, ensuring design control compliance, supporting regulatory submissions, and managing cross-functional teams including CMC, Regulatory, Quality, and Manufacturing. The role involves vendor management, lifecycle support, and risk management aligned with standards such as ISO 13485, ISO 14971, and IEC 62366. Qualifications required include a bachelor’s in Mechanical or Biomedical Engineering with 8+ years of relevant experience, especially in combination product development supporting late-stage development through commercialization. Technical expertise needed encompasses design controls, risk management, human factors, and regulatory knowledge relevant to biologics delivery systems. Leadership skills are essential for managing matrixed teams, vendors, and stakeholder communication. High-value specifics involve biologics, neuroendocrine indications, late-stage development, and GxP compliance. The position is based in Boston with a hybrid work model and may require some travel (~10-20%).