Senior Systems Engineer

Allergan; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a Senior-level Systems Engineer to join the Combination Product Development team in North Chicago, IL. You will drive multi-disciplinary integration, risk assessment, and system validation for innovative drug/device combos.

You will lead global engineering activities, collaborate with external partners, and ensure designs meet IEC/ISO and regulatory requirements while delivering robust patient-centric solutions.

Qualifications

• Experience across full product development from concept to release.
• Ability to work with global teams and external partners.
• Familiarity with device regulatory frameworks (ISO 13485, 21 CFR 820, MDR).

Responsibilities

• Lead cross-disciplinary systems engineering efforts for drug/device combos.
• Define needs, use cases, traceability, risk management and system validation.
• Coordinate with external vendors and global engineering partners.
• Provide technical leadership ensuring safety and regulatory compliance.

Skills

Systems engineering leadership

Cross-functional collaboration

Regulatory compliance

Requirements management

Risk assessment

System architecture

Vendor management

Regulatory standards knowledge

Education

Bachelor’s degree

Master’s degree

PhD

Tools

Requirements management tools

V-model

Context diagrams

Architecture diagrams

Interface management

Job description

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,XandYouTube.

Job Description

AbbVie is seeking a Senior-level Systems Engineer to join their Combination Product Development team. This individual will be responsible for 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, integrationof 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 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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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