Device Development Engineer- Project Leadership

Role Summary

Device Development Engineer to join the project lead team. Responsible for end-to-end development of a device combination product and/or platform delivery system within a specific therapeutic area, providing leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration for the device.

Responsibilities

• 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.
• Integrates 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 meets regulatory and quality requirements (21 CFR Part 3 and 21 CFR 820.30).
• Supports management in related clinical and commercial regulatory activities related to device development (e.g., IND/IMPD, BLA Submission, Clinical Pharmacy Manuals).
• Understands design inputs and outputs of multiple delivery systems and their impact on end users.
• Supports management and/or therapeutic area device project leads in strategic product launch and go-to-market plans for device development.

• 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.

Qualifications

• Device Development Engineer: 2+ years of relevant experience
• Sr. Device Development Engineer: 5+ years of relevant experience
• Or equivalent combination of education & experience

Education

• B.S in Engineering