Senior Systems Engineer

About the role

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 & 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. 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 testing and multi-cultural awareness will help make you successful in this position.

Must have demonstrated technical leadership and ownership, and the ability to provide guidance and direction to less experienced technical personnel.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.