Senior Device Development Engineer

Regeneron Pharmaceuticals•Valley, AL

2d•$75,300 - $143,900•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Device Development Engineer to join our New Technologies, Combination Products Innovation team. This engineer will be responsible for front-end innovation projects and scenario planning to support Regeneron’s growing pipeline, working cross-functionally to define patient, user, and business needs, identify and advocate for novel device solutions and opportunities, and manage early-stage device design and development programs.

Requirements

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)
Experience with delivery device branding/marketing is preferred

Responsibilities

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