Systems Engineer Jobs

About The Position

Requirements

• Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience.
• Thorough theoretical and practical understanding of own scientific discipline.
• Effective writer and communicator of research or other regulatory materials.
• Leadership experience required, including the ability to influence and negotiate internally and externally as part of global engineering teams.
• Experience through full product development from initial concept to release to market.
• Expertise in design and development processes that conform to standards including IEC 60601, ISO 14971, IEC 62304, 11608, and the ability to work in a regulated environment in compliance with ISO 13485 and 21 CFR 820 and MDR.
• Experience in user and stakeholder need definition; requirements definition; risk management, product architecture.
• Strong analytical and communication skills.
• Experience with requirements management tools, V-model implementation, context diagrams, architecture diagrams, and interface management.
• Demonstrated technical leadership and ownership.

Nice To Haves

• Familiarity with device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis.
• Strong analytical, decision making and communication (spoken and written) skills.
• Experience in vendor communication, management, deliverable acceptance testing and multi-cultural awareness.

Responsibilities

• Lead and drive User and Stakeholder Needs Definition, Use Case Analysis, traceability, Standards Coverage Analysis, System/Sub-System Requirements Definition, integration of third-party development activities, System Architecture & integration, Risk Management Planning and reporting, System Risk Assessment, Use Error Risk assessments, integration of drug product development activities, and design validation.
• Contribute to broadening the understanding and implementation of appropriate systems engineering principles within AbbVie, potentially involving internal and external activities.
• Develop and foster relationships with external Engineering Services firms and third-party development partners in Europe, India, Asia, and the US, requiring periodic face-to-face visits.
• Provide technical leadership in areas of responsibility, ensuring systems design and documentation meet safety and regulatory compliance requirements.
• Create and manage project schedules and help identify project risks and develop mitigation plans.
• Interface with 3rd party vendors, including communication, management, deliverable acceptance testing, and demonstrating multi-cultural awareness.
• Provide guidance and direction to less experienced technical personnel.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs