Sr Staff Device Engineer

Role: Senior Staff Device Engineer specializing in combination product devices within Takeda's Commercial Device Engineering team, responsible for lifecycle management of on-market drug delivery devices. Responsibilities: lead technical aspects of device lifecycle, manage change controls, manufacturing validation, complaint investigations, design control activities, and post-market surveillance; coordinate device qualification, tech transfer, and risk management; ensure compliance with device and quality regulations (ISO13485, ISO14971); collaborate cross-functionally with drug development, quality, regulatory, and external partners. Requirements: PhD in Mechanical, Electrical, Biomedical Engineering, or related field with 3+ years (PhD), 5+ years (MS), or 8+ years (BA/BS) experience; SME in drug delivery systems such as PFS, pens, autoinjectors; expertise in design controls, manufacturing processes, quality systems, and lifecycle management for combination products; knowledge of cGMP, regulatory guidance, and technical authoring skills. Preferred: experience with device complaint investigations, change controls, and post-market activities. HighValue: focus on drug delivery devices, combination products, lifecycle management, post-market surveillance, technical leadership in a GxP environment, working with external CRO/CMO, based in Lexington, MA, with potential cross-functional interaction with regulatory, quality, and drug development teams.