Remotely
requirements managementmdriso 13485iso 14971iec 6230421 cfr 820v modeliec 60601
Job Description
📋 Description
- Lead across engineering teams to define needs, use cases, traceability and requirements
- Define system architecture and integrate third-party development
- Manage risk, use error risk assessments and design validation
- Collaborate with external Engineering Services globally (Europe, India, Asia, US)
- Ensure safety and regulatory compliance of system designs
🎯 Requirements
- Bachelor's or higher; extensive engineering experience (mid-senior level)
- Deep knowledge of IEC 60601, ISO 14971, IEC 62304, 11608; ISO 13485 & 21 CFR 820, MDR
- Experience with requirements management, V-model, context/architecture diagrams, interface
- Device design controls, system decomposition, simulations, error budgeting, sensitivity analysis
- Strong analytical and communication skills; project scheduling and risk mitigation
- Experience interfacing with 3rd party vendors and cross-cultural teams
🎁 Benefits
- Comprehensive benefits package: PTO, medical/dental/vision, and 401(k)
- Eligible for long-term incentive programs
- AbbVie is an equal opportunity employer
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