Regeneron is currently looking for a Principal/Staff Device Development Engineer to join our project lead team. This is a non-lab based position. They will drive the end-to-end platform development of a device combination products and/or innovative platform drug delivery systems, that will eventually be utilized by our patients on the market. In this role you will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal and external stakeholders, for the internally design platform delivery systems. A typical day for a Principal/Staff Device Development Engineer might include: Leads multidisciplinary engineering project teams (Design Engineering, Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy partners. Targeted to have direct reports or mentees within the device project leadership team/organization, to support multiple platform device developments. Responsible for all user needs and requirements to be validated through design and development Develops, leads, and communicates development program plans, risks, timelines, and budgets to internal and external collaborators. Manages relationships with all CDMOs and manufacturers related to device component manufacturing. Support the integration of developed device platforms with the pairings of upcoming drug products within the Regeneron pipeline, based on need and scope. Supports internal and external manufacturing teams around relevant design and process development information transfers (understands design for manufacturing principles, is a plus). Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21 CFR 820.30) Supports and aligns all clinical and commercial regulatory activities related to device development, including (not limited to): 510K Submission, Biologics License Application (BLA) Submissions, Information Requests (IRs) Defines technical specifications and design requirements in collaboration with engineering teams (product design, manufacturing, verification, packaging etc.) Manages product development timelines and critical milestones with internal design teams and external partners/CDMOs. Leads all aspects of product testing and quality assurance processes for the specific device development. Drives strategic product launch and go-to-market plans with new technologies management and combination product leadership teams. Understands crucial design inputs and outputs of different types of delivery systems (different delivery sites) and how it can impact end users. Builds comprehensive product roadmaps and helps supports strategic plans to ensure a clear, compelling product vision is articulated to senior leadership. Crafts and analyzes cases to support value propositions of new delivery systems being developed for the Regeneron Pipeline. This role might be for you if you: Successfully managing sophisticated, multi-disciplinary development projects. Understand regulatory compliance and clinical trial processes (thorough understanding of relevant FDA regulations, particularly 21 CFR 820.30 and 21 CFR Part 3, is a plus). Understand design of manufacturing principles and component manufacturing (ie: plastic molding), is a plus. Possess strong project management and interpersonal skills, analytical and problem-solving capabilities. Have experience with regulatory submissions and clinical protocol development. Can balance business objectives with technical constraints. Enjoy working in a fast-paced, multifaceted research and development environment. Are willing/able to travel occasionally for collaborator meetings, audits, and project coordination. To be considered for the Principal/Staff Device Development Engineer you must have a B.S in Engineering; biomedical engineering or mechanical engineering is preferred. You must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels you must have the following: Principal Device Development Engineer: 8+ years of relevant experience Staff Device Development Engineer: 10+ years of relevant experience Or equivalent combination of education and experience Previous experience in combination product/medical device development or similar area is required. Experience with design history file management (21CFR 820.30), is preferred. Level is determined based on qualifications relevant to the role. #LI-MB1