Senior Engineer II, Device Development

Role: Senior Engineer II in Device Development responsible for designing, developing, and managing lifecycle activities of patient-centric drug delivery devices and combination products. Objectives include supporting new product development and sustaining existing products by applying engineering principles, evaluating emerging technologies, and collaborating with internal teams and external partners. Responsibilities encompass managing design history files, risk assessment, technical investigations, device change management, and contributing to regulatory documentation and filings. Required qualifications include a bachelor’s degree in biomedical, electrical, mechanical, or related engineering with at least 6 years of experience in device or combination product development, specifically with drug delivery systems like autoinjectors or prefilled syringes, and knowledge of relevant standards (ISO 13485, 21 CFR Part 4). Preferred qualifications include an advanced degree, experience with requirements and risk management software, and familiarity with AI tools to streamline workflows. High-value specifics involve expertise in electromechanical or connected delivery systems, regulatory compliance in US/EU, and experience supporting product launch from concept to commercialization. The role reports to management and entails hybrid work at headquarters in Cambridge, MA, with no travel explicitly specified.