Purpose:

AbbVie is looking for a Sr. Systems Engineer to join their Combination Product Development team.  This individual will contribute to the development and launch of exciting new drug / device combination products.

As a Sr. Systems Engineer, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance. 

Responsibilities:

You will be responsible for working across engineering teams to lead and drive the following:

• User and Stakeholder Needs Definition
• System Architecture & Integration
• Use Case Analysis
• Traceability
• Standards Coverage Analysis
• Risk Management Planning and reporting
• System Risk Assessment
• Use Error Risk Assessments
• System/Sub-System Requirements Definition
• Integration of Third-Party Development activities
• Integration of Drug Product Development activities
• Design Validation

In addition, you will be responsible for contributing to broadening the understanding and implementation of appropriate systems engineering principles within AbbVie.  It is expected that the systems engineering activities for which you will be responsible may be done internally and externally.   The external systems engineering activities will require you to develop and foster relationships with these external Engineering Services firms and third-party development partners who may be in Europe, India, Asia, and US, and in addition to regular WebEx/teleconferences, will require periodic face-to-face visits. You will be responsible for providing technical leadership in your areas of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirements.

Preferred Qualifications:

• Leadership experience is required that includes the ability to influence and negotiate internally and externally as a part of global engineering teams.
• Experience through full product development from initial concept to release to market is required.
• 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 to ISO 13485 and 21 CFR 820 and MDR.
• Experience is required in user and stakeholder need definition; requirements definition; risk management, product architecture.
• The candidate must have strong analytical and communication skills.  In addition, they must have experience with requirements management tools, V-model implementation, context diagrams, architecture diagrams, and interface management.
• The candidate should be familiar with device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis. 
• Other attributes include strong analytical, decision making and communication (spoken and written) skills. It is expected that you will create and manage project schedules and help identify project risks and develop mitigation plans.