Senior Systems Engineer II or Principal Systems Engineer I - R&D Combination Products Development - 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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

AbbVie is looking for a Senior Systems Engineer II / Principal Systems Engineer I to join their Combination Product Development team in R&D. This individual will contribute to the development of exciting new drug / device combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on peoples lives.

As a Senior Systems Engineer II / Principal Systems Engineer I, you will be responsible for integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of drug delivery systems from syringes to autoinjectors to complex electromechanical pumps. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.

This position is based in Lake County, IL, US.

Core Job Responsibilities:

You will be responsible for contributing to broaden the understanding and implementation of appropriate product development engineering principles within the Design Controls process with particular focus on Design Inputs and Risk Management. It is expected that the engineering activities for which you will be responsible may be done internally and externally. The external engineering activities will require you to develop and foster relationships with Engineering Services firms and third-party development partners who may be in Europe, Asia, and US, and in addition to regular WebEx/teleconferences, will require periodic face-to-face visits.

You will be responsible to drive the following activities/deliverables:

• 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
• Reliability Planning / Assessments

Provide technical leadership in your areas of responsibility and ensure the Design History File meets all regulatory compliance requirements. It is expected at this level that you will contribute to raising the bar to how we execute in combination product development. This includes the identification and leadership of improvement initiatives, coaching / training individuals, looking for new ideas to stimulate innovation and connect unrelated concepts.

You will be responsible for providing technical leadership in your areas of responsibility and ensuring the systems design and documentation meet all safety and regulatory compliance requirements.

• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Experience through full product development from initial concept to release to market is required.
• Expertise in product development from initial concept to release to market is desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and 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.
• The candidate must have strong analytical and communication skills and should be self-driven.
• 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.
• It is expected at this level that you contribute to raising the bar on how we develop combination products. This includes the identification and leadership of improvement initiatives, coaching / training individuals, look for new ideas to stimulate innovation and connect unrelated concepts, generate original or unique ideas.
• Travel will be required, as necessary. (10%)

Experience:

• BS in Engineering, Science, or closely related discipline with 12+ years of experience or MS with 10+ years of experience or PhD with 4+ years of experience.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.

Position will be hired based on level of experience.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

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