Senior Device Development Lead: End-to-End & Compliance

Biopharma Careers; United States; On-site; USD 75,000 - 144,000; Full time

Job summary

Regeneron is seeking a Senior Device Development Engineer to lead end-to-end development of a device combination product and platform delivery system. You will guide multidisciplinary teams, define requirements, and ensure DHF compliance across FDA-regulated processes.

The role emphasizes project leadership, risk management, and collaboration with manufacturing, QA, and regulatory groups to support go-to-market strategies and lifecycle management.

Qualifications

• BS in Engineering with 5+ years of relevant experience.
• Experience in product/project management or leadership activities.
• Strong knowledge of FDA regulations (design controls) and DHF management.

Responsibilities

• Leads multidisciplinary engineering teams through the full design and development lifecycle of combination products.
• Defines product requirements and design inputs with stakeholders; ensures user needs are validated.
• Develops program plans, timelines, and budgets; communicates with internal and external teams.

Skills

Project management

Regulatory compliance

Cross-functional leadership

Design controls

Quality assurance

Education

BS in Engineering

Job description

Regeneron is seeking a Senior Device Development Engineer to lead end-to-end development of a device combination product and platform delivery system. You will guide multidisciplinary teams, define requirements, and ensure DHF compliance across FDA-regulated processes.

The role emphasizes project leadership, risk management, and collaboration with manufacturing, QA, and regulatory groups to support go-to-market strategies and lifecycle management.