Senior Systems Engineer

Senior Systems Engineer Full-time Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube . Job Description AbbVie is seeking a Senior-level 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, 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. 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 requirement. Qualifications 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. Possess thorough theoretical and practical understanding of own scientific discipline. Effective writer and communicator of research or other regulatory materials. 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. This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance