Senior Engineer/Manager, Device Development — Combination Products

Role: Senior Engineer/Manager, Device Development — Combination Products, leading technical execution and program management for autoinjectors, prefilled syringes, or wearable injectors within biopharma drug development pipelines. Responsibilities include overseeing device design control documentation, supporting human factors/usability engineering activities, standardizing platform components, and managing external supplier relationships and technology transfers. The role also involves providing manufacturing support during clinical and commercial phases, ensuring quality and compliance, and collaborating with cross-functional teams (Regulatory, Quality, CMC, Clinical). Qualifications: BS/MS in Mechanical, Biomedical Engineering; 5–7 years’ experience in device development, especially for combination products like autoinjectors or prefilled syringes; expertise in design controls, ISO standards, FDA regulations, and 3D modeling (SolidWorks). Preferred: experience with human factors studies, program lifecycle management, and biologic injectables; prior manufacturing site support. HighValue: biologics, combination devices, clinical and commercial manufacturing, regulatory documentation, cross-functional collaboration, international travel (~20–30%). WorkSetup: Hybrid Waltham, MA with travel.