Sr. Device Development Engineer (Project Leadership)

Role Summary

Senior Device Development Engineer (Project Leadership) to drive the end-to-end development of a device combination product and/or platform delivery system within a specific therapeutic area. Provides leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal and external partners for the device portion of the combination product.

Responsibilities

• 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.
• 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 (21CFR Part 3 and 21 CFR 820.30).
• Supports management in related clinical and commercial regulatory activities related to the device development (e.g., IND/IMPD, BLA Submission, Clinical Pharmacy Manuals).
• 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.

Qualifications

• B.S. in Engineering with 5+ years of relevant experience, or an equivalent combination of education and experience. Previous experience in product management, project management, and/or project leadership activities is required.
• Understand FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
• Experience with design history file management (21 CFR 820.30).
• Strong project management and interpersonal skills with analytical and problem-solving capabilities.
• Ability to balance business objectives with technical constraints.
• Ability to work effectively across multiple functional teams.
• Willingness and ability to travel for partner meetings, audits, and project coordination activities.

Education

• B.S. in Engineering (required)

Skills

• Leadership and cross-functional collaboration
• Regulatory compliance and design controls
• Device development and product lifecycle management
• Project/program management
• Strong communication and problem-solving