Sr. Device Development Engineer (Project Leadership)

About the role

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.

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.

Requirements

• 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.
• Willing and able to travel for partner meetings, audits, and project coordination activities.

Qualifications

• 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.

Skills

• Strong project management and interpersonal skills.
• Strong analytical and problem-solving capabilities.
• Experience with design history file management (21 CFR 820.30).
• Understanding of relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$75,300.00 - $143,900.00 annually

Schedule

Full time