Principal Device Development Engineer - Project Leadership

Regeneron is seeking a Principal/Staff Device Development Engineer to join our project leadership team. They will drive the end-to-end development of device combination products and/or platform delivery systems, within a specific therapeutic area (Ophthalmic, Hematology, Cardio-metabolic, 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 developments in the designated therapeutic area.

A typical day for a Principal 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 stakeholders.
• Responsible for all user needs and requirements to be validated through design and development.
• Ensures comprehensive Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30).
• Supports and aligns all clinical and commercial regulatory activities related to device development.
• Defines technical specifications and design requirements in collaboration with engineering teams (manufacturing, verification, packaging etc.)
• Develops, manages, and communicates development program plans, risks, timelines, and budgets.
• Leads all aspects of product testing and quality assurance processes for the device development.
• Drives product launch and go-to-market plans with CMC PM (Chemistry, Manufacturing & Controls Program Management) and other collaborators and project management teams.
• Understands crucial design inputs and outputs of different types of delivery systems (different delivery sites) and how it can impact end users.
• Seeks out continuous improvements and collaborative opportunities to improve device development processes and collaborator relationships.
• Leads post-launch life cycle management initiatives and product improvements.
• Represents end-user and device/product needs within the organization.
• May have people leadership/mentoring responsibilities.
   

This role might be for you if you:

• Can successfully manage sophisticated, multi-disciplinary development projects.
• Have a thorough understanding of relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
• Understand design history file management (21CFR 820.30).
• Possess project management and interpersonal skills and strong analytical and problem-solving capabilities.
• Can work optimally across multiple functional teams.
• 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 and able to travel for partner meetings, audits, and project coordination activities.
   

To Be Considered for the Principal 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 your 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 & 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 and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualifie