Senior Device Development Engineer (Project Leadership

Sr. Device Development Engineer

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 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 (21
  
  CFR 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 or relevant experience; or equivalent combination of education & 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.