Senior Device Development Engineer

Regeneron develops life-changing medicines for people with serious diseases and is seeking a Senior Device Development Engineer for its New Technologies, Combination Products Innovation team. The role leads front-end innovation, scenario planning, early-stage device design and development, and cross-functional strategy for drug-device combination products and delivery systems.

Responsibilities

• Monitor drug delivery device technologies and competitor activity to keep our device strategy ahead of the curve
• Build relationships with molecule development teams and monitor portfolio to identify device requirements well before they become critical-path decisions, ensuring device readiness never bottlenecks program timelines
• Evaluate and develop device strategy proposals across a diverse portfolio of therapeutics, balancing patient needs, drug product constraints, and commercial considerations through strong relationships with stakeholders
• Project management of early device development projects, coordinating cross-functionally
• Lead and influence drug-device combination product scenario planning for new and lifecycle management programs, collaborating cross-functionally to gather stakeholder input, drive strategic decisions, and gain buy-in on long-term device strategies within therapeutic areas
• Research, monitor, and analyze drug delivery system industry and market trends, competitive landscapes, internal pipeline drug delivery needs, and patient/user needs to identify innovation opportunities and advise device strategy
• Perform technical feasibility evaluations and due diligence assessments, working with external strategic partners to drive toward innovative device solutions
• Lead early-stage drug delivery system design efforts with a multi-functional team, translating business needs and stakeholder requirements into comprehensive project plans and innovative product design
• Generate insights through exploratory, user, and foundational research to inform the drug delivery system portfolio, collaborating with technical teams, human factors, commercial, clinical, and other subject matter experts as applicable
• Maintain a culture of continuous improvement that strives to ensure safety and efficacy while accelerating delivery of commitments
• Represent Regeneron and the device teams at appropriate industry meetings and forums
• Demonstrate strong communication, presentation skills and can strategic alignment
• Possess project management skills and can work effectively across multiple functional teams

Preferred

• Biomedical Engineering or Mechanical Engineering is preferred
• Experience with delivery device branding/marketing is preferred
• Delivery Device Branding
• Delivery Device Marketing

Benefits

• Annual bonuses or other incentive plans, depending on country and role
• Equity awards, depending on country and role
• Pension or retirement benefits, depending on country and role
• 401(k) company match, depending on country and role
• Health and wellness programs, depending on country and role
• Fitness centers, depending on country and role
• Insurance benefits (e.g. medical, dental, vision, life and disability), depending on country and role
• Paid time off, depending on country and role
• Family support benefits, depending on country and role

Company

• Develops and commercializes biopharmaceutical medicines for serious diseases
• Tarrytown, New York, USA
• http://www.regeneron.com/
• Founded in 1988
• 10001+ employees

Qualifications

• BS in Engineering field; Biomedical Engineering or Mechanical Engineering is preferred
• Device Development Engineer: 2+ years of experience
• Sr. Device Development Engineer: 5+ years of experience
• Experience with design history file management (21 CFR 820.30)
• Biomedical Engineering or Mechanical Engineering is preferred
• Experience with delivery device branding/marketing is preferred

Required skills

• , Drug Delivery Device Development, Combination Product Development, Design History File Management, 21 CFR 820.30, Technical Feasibility Evaluation, User Research, Device Strategy Development

Preferred skills

• Project Management

Experience

• 2+ years