Sr. Device Development Engineer (Project Leadership)

Job Description Regeneron is seeking a Sr. Device Development Engineer to join our project lead team. The Sr. Device Development Engineer will drive the end‑to‑end development of a device combination product and/or platform delivery system, within a specific therapeutic area (Ophthalmic, Immunology/Inflammation, Cardiometabolic, etc.). They will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi‑functional collaboration with internal and external partners, for the combination product device. A typical day for a Sr. Device Development Engineer might include: Leads multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of a combination product development within the Regeneron Pipeline. Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy collaborators. Defines technical specifications and design requirements in collaboration with engineering teams (manufacturing, verification, packaging etc.) Responsible for all user needs and requirements to be validated through design and development. Develops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members. Integrate device development activities with Chemistry Manufacturing Controls (CMC) and Global development timing and goals. Supports global internal manufacturing and external manufacturing teams around relevant design and process development information transfers. Leads all aspects of product testing and quality assurance processes for the specific device development. Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30). Supports management in related clinical and commercial regulatory activities that is related to the device development (ie: IND/IMPD, BLA Submission, Clinical Pharmacy Manuals etc.) Understands design inputs and outputs of multiple delivery systems and how it can impact end users. Supports management and/or therapeutic area device project leads, in strategic product launch and go‑to‑market plans for the device development. This Role Might Be For You If You Understand relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30. Have experience with design history file management (21 CFR 820.30). Possess strong project management and interpersonal skills and strong analytical and problem‑solving capabilities. Can balance business objectives with technical constraints. Can work effectively across multiple functional teams. Enjoy working in a fast‑paced, multifaceted research and development environment. Are willing and able to travel for partner meetings, audits, and project coordination activities. To be considered for the Device Development Engineer you must have a B.S in Engineering and 5+ years of relevant experience; or an equivalent combination of education and experience. Previous experience in product management/project management and/or project leadership related activities is required. Level is determined based on qualifications relevant to the role. Salary Range (annually) $75,300.00 – $143,900.00 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. For jobs in Canada: this posting is for an existing position. #J-18808-Ljbffr Regeneron