Sr Device Engineer

Role: Senior Device Engineer supporting development and lifecycle management of combination drug-device products (prefilled syringes, auto-injectors, on-body injectors) for biologic therapies. Responsibilities: lead design control activities, perform technical evaluations of device components, apply systems engineering to define requirements and interfaces, develop and execute test strategies for product performance, and support lifecycle activities like change controls and investigations. Collaborate cross-functionally with Regulatory, Quality, Manufacturing, and external partners to ensure compliance and device performance. Requirements: BS with 4-6 years or MS with 2-4 years in pharmaceutical, biotech, or medical device development; hands-on experience with mechanical testing, materials evaluation, and device design support; familiarity with design controls (21 CFR 820, ISO 13485), risk management, and test validation is preferred. High-value details: focus on combination products in biologics, regulated environment, supporting lifecycle management, and technical evaluation of delivery devices. Work setup specifics not provided.