Senior Systems Engineer

AbbVie seeks a Senior Systems Engineer for their Combination Product Development team to lead integration of multiple disciplines in drug-device product design. The role requires systems engineering expertise across user needs definition, requirements management, risk assessment, and regulatory compliance throughout the product lifecycle.

Responsibilities

• Lead user and stakeholder needs definition, use case analysis, and traceability across teams
• Define system and sub-system requirements, architecture, and integration strategies
• Manage risk assessment including use-error analysis and system risk planning
• Coordinate with internal teams and external vendors across multiple geographies
• Ensure design documentation meets safety, regulatory, and compliance requirements

Requirements

• Bachelor's degree plus 12 years experience, or Master's plus 10 years, or PhD plus 4 years
• Expertise in IEC 60601, ISO 14971, IEC 62304, ISO 13485, and 21 CFR 820 compliance
• Full product development experience from concept through market release
• Proficiency with requirements management tools, V-model, architecture diagrams, and interface management
• Leadership experience with ability to influence and negotiate across global engineering teams
• Strong analytical skills and technical communication abilities for regulatory documentation
• Experience with vendor management, device design controls, and risk assessment methodologies