Senior Device Development Engineer

Responsibilities:

• Lead and influence drug-device combination product scenario planning for new and lifecycle management programs; collaborate cross-functionally to gather stakeholder input, drive strategic decisions, and secure buy-in on long-term device strategies.
• Research, monitor, and analyze drug delivery system industry/market trends, competitive landscapes, internal pipeline needs, and patient/user needs to identify innovation opportunities and advise device strategy.
• Conduct technical feasibility evaluations and due diligence; work with external strategic partners to drive innovative device solutions.
• Lead early-stage drug delivery system design with a cross-functional team; translate business needs and stakeholder requirements into project plans and product design.
• Conduct exploratory/user/foundational research to inform the drug delivery system portfolio; collaborate with technical, human factors, commercial, clinical, and other experts.
• Promote continuous improvement focused on safety and efficacy while accelerating delivery.
• Represent device teams at industry meetings; communicate and present effectively; demonstrate strategic alignment and project management across functional teams.

Qualifications:

• BS in an Engineering field; Biomedical Engineering or Mechanical Engineering preferred.
• Device Development Engineer: 2+ years experience; Senior Device Development Engineer: 5+ years experience.
• Experience managing design history files (21 CFR 820.30).
• Delivery device branding/marketing experience preferred.