Senior Systems Engineer

Role: Senior Systems Engineer in AbbVie's Combination Product Development team, focusing on integrating multi-disciplinary engineering efforts for drug/device combination products. Responsibilities: lead stakeholder needs definition, use case analysis, system requirements, architecture, risk management, and design validation; foster external partner relationships; ensure compliance with safety and regulatory standards such as IEC 60601, ISO 14971, IEC 62304, 21 CFR 820, MDR, and ISO 13485. Qualifications: Bachelor’s degree with 12+ years, Master’s with 10+ years, or PhD with 4+ years of experience in systems engineering; strong leadership and communication skills; extensive experience in full product lifecycle development, design controls, risk management, and working within regulated environments; proficiency with requirements management tools, system architecture, interface management, and vendor collaboration. High-Value: focus on combination products, regulatory compliance, risk assessments, design validation, and external partnerships across global regions. Work Setup: not specified; likely hybrid given external engagement requirements.