AbbVie is looking for a Senior Systems Engineer I/II to join our Device Development team to conceive and execute novel engineering research and development that achieves projects and area goals. This is a key role with a direct impact on AbbVie’s exciting and rapidly growing portfolio of combination products, with a major focus on Eye Care and Neurotoxins products.

　　Within Device Development, the System Engineering group is responsible for the integration of the inputs from multiple disciplines to ensure robust patient-centric product design and performance.

　　As a Senior Systems Engineer, you would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of innovative drug delivery systems including Electromechanical, Mechanical-autoinjector, auto applicators, Prefilled Syringes for various therapies.

　　The position is based in Irvine, CA, US. Domestic and International travel may be required, as necessary. (Up to 10%).

　　Key Responsibilities

　　Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.

　　Effectively function as a Systems Engineer, to understand and implement product development engineering principles within the Design control process with a focus on Design inputs and Risk Management.

　　Responsible for driving User/Stakeholder needs, Use case analysis, Traceability, Standards coverage analysis, integration of third-party development, System Architecture and integration, Risk Management file, and Reliability planning/assessment across combination product development functions including external partners.

　　Provide technical leadership in your areas of responsibility and ensure Design History File meets all global regulatory compliance requirements.

　　Support of delivery system reliability and analytical modeling of key performance attributes

　　Qualifications

　　Job level will be commensurate with experience

　　BS in Engineering Science, or equivalent related engineering education and extensive, typically 10+ years of experience; MS or equivalent education with typically 8+ years of experience.

　　Experience in leading system architecture and successful integration for various Combination products including mechanical, electromechanical, and pre-filled syringes/cartridges, preferably in the drug delivery space

　　Detailed understanding of principles and practice of Design Controls (CFR 820.30, 21 CFR Part 4 / ISO 13485) and Risk Management (ISO 14971) & EU MDR preferred.

　　Expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management and reliability.

　　Expertise in DHF management and creating various Design Control documents in compliance with regulations.

　　Ability to drive multiple design development projects across multidisciplinary function.

　　Clear and concise written and verbal communication while working cross functionally without direct authority

　　A keen eye for identifying project risks and its mitigation to ensure compliance.

　　Ability to prioritize and adapt in rapidly changing environment and stakeholders need.

　　Design for Six Sigma experience is desired

　　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 short-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.

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　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.