Sr. Engineer - Combination Product Inhalation Device Lead

Role: Senior Engineer leading combination product inhalation device development, focusing on dry powder inhaler (DPI) platforms. Objectives include system engineering, device design, and integration to support Amgen’s inhalation biologics portfolio. Responsibilities encompass owning DHF/DDP documentation, translating user needs into device requirements, leading design verification strategies, and managing supplier integrations. The role involves cross-functional collaboration with regulatory, quality, analytical, manufacturing, and clinical teams to ensure device performance, aerosolization, and dose delivery meet product objectives. Qualifications: Doctorate or Master’s with 2+ years, Bachelor’s with 4+ years, or equivalent experience in biomedical or engineering fields. Preferred skills include experience with capsule-based DPI platforms, aerosol characterization, supplier oversight, and supporting regulatory submissions for drug-device combination products. High-Value: Expertise in inhalation device design, aerosol science, risk management, and lifecycle support of combination products; experience with global regulatory processes; and knowledge of fluid dynamics and particle dispersion are advantageous. Work setup details and travel expectations are not specified.