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 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), is a plus. 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 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. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.   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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $75,300.00 - $143,900.00