Senior Systems Engineer

Posted 4 Days Ago
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North Chicago, IL, USA
In-Office
110K-209K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Lead systems engineering for drug/device combination products across disciplines and third-party partners. Define user/stakeholder needs, system/subsystem requirements and architecture, perform risk and use-error assessments, ensure standards/regulatory compliance, manage vendor integration, and provide technical leadership through design validation to product launch.
Summary Generated by Built In
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 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.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Skills Required

  • Bachelor's degree (or Master's/PhD with equivalent experience) with typically 12/10/4 years respectively
  • Thorough theoretical and practical understanding of scientific/engineering discipline
  • Effective written and verbal communication of regulatory or research materials
  • Leadership experience with ability to influence and negotiate across global engineering teams
  • Experience through full product development lifecycle from concept to market release
  • Expertise with medical device and combination product standards and regulated environments (IEC 60601, ISO 14971, IEC 62304, ISO 11608, ISO 13485, 21 CFR 820, MDR)
  • Experience in user and stakeholder needs definition, requirements definition, risk management, and product architecture
  • Experience with requirements management tools, V-model implementation, context and architecture diagrams, and interface management
  • Familiarity with device design controls, system decomposition, operational simulations, error budgeting, and sensitivity analysis
  • Experience interfacing with third-party vendors, vendor management, deliverable acceptance testing, and multicultural collaboration
  • Demonstrated technical leadership and ability to mentor and direct less experienced engineers

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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