Manager, Device Development & Manufacturing

Role: Manage the development and manufacturing of injectable drug delivery devices within biopharma, focusing on technologies like prefilled syringes and autoinjectors. Responsibilities: oversee vendor selection, support development from technology choice through clinical trials to commercialization, ensure regulatory compliance, lead design verification and validation activities, and collaborate across teams on device specifications, risk assessments, and process validation. Qualifications: 6+ years in process or product engineering, preferably within medical devices or pharmaceutical manufacturing; BS/BA in engineering or life sciences, with experience in combination products and knowledge of standards such as ISO 13485 and regulations like 21 CFR Part 4. High-Value: expertise in device design and development, regulatory compliance for combination products, experience with human factors assessments, and familiarity with emerging autoinjector technologies. Work Setup: hybrid or remote based in Waltham, MA, with up to 15% travel.