Sr. Systems Engineer

AbbVie•North Chicago, IL

7d•$109,500 - $208,500•Onsite

About The Position

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.

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 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 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.
Experience in vendor communication, management, deliverable acceptance testing and multi-cultural awareness.

Responsibilities

Working across engineering teams to 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.
Contributing to broadening the understanding and implementation of appropriate systems engineering principles within AbbVie.
Developing and fostering relationships with 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.
Providing technical leadership in areas of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirements.
Creating and managing project schedules and help identify project risks and develop mitigation plans.
Interfacing with 3rd party vendors, including vendor communication, management, deliverable acceptance testing and multi-cultural awareness.
Providing guidance and direction to less experienced technical personnel.