Device Development Engineer (Project Leadership)

Regeneron is seeking a Device Development Engineer to join our project lead team. The 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 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. - 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. - 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). - 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 to meet regulatory and quality requirements. - Supports management in related clinical and commercial regulatory activities related to device development. - Understands design inputs and outputs of multiple delivery systems and how they 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. - Possess strong project management and interpersonal skills and strong analytical and problem-solving capabilities. - Can balance business objectives with technical constraints. - 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 be willing and able to work Monday-Friday, 8am-4:30pm. You must have a B.S in Engineering. For various levels you must have the following: - Device Development Engineer: 2+ years of relevant experience. - Sr. Device Development Engineer: 5+ years of relevant experience. Previous experience in product management/project management/ and/or project leadership related activities is preferred. Level is determined based on qualifications relevant to the role.