Device Development Engineer (Project Leadership)

Regeneron Pharmaceuticals • Valley, AL

3d • Onsite

About The Position

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.

Requirements

• 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.
• Associate Device Development Engineer: 0-2 years of relevant experience
• Device Development Engineer: 2+ years of relevant experience
• Sr. Device Development Engineer: 5+ years of relevant experience
• Understands relevant FDA regulations, particularly 21 CFR Part 3 and 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.

Nice To Haves

• Have experience with design history file management (21 CFR 820.30), is a plus.
• Previous experience in product management/project management/ and/or project leadership related activities is preferred.

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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees