AbbVie

Sr Systems Engineer Combination Products

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Feb 21, 2021
Ref
2009561
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Senior Systems Engineer Combination Products works as systems lead on cross-functional project teams in support of combination products and medical devices. Activities include leading creation and integration of product design documentation to enable robust requirements, test planning and risk management in support of product development, manufacturing transfers and investigations, supplier driven design changes, and product enhancements. Products are intended for drug delivery and include plastic disposable and implantable products, injection devices, and electromechanical devices with integrated software. Work is conducted in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485) as applicable.

Core Job Responsibilities:

Working as member of cross-functional team to lead and drive the following:
  • 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


Responsibilities
  • Independently lead application of systems engineering concepts and practices in development and maintenance of medical devices (especially electromechanical devices and software)
  • Work independently within expertise and drive integration of cross functional input to design deliverables
  • Maintain compliance and work in a regulated environment
  • Support development of project schedules and define deliverables
  • Author technical reports and design documentation
  • Summarize and present results to project teams and program stakeholders
  • Mentor junior personnel
  • Understand and adhere to corporate standards regarding code of conduct, safety, and GxP compliance.

Qualifications

Qualifications:
  • 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 EU MDR.
  • Experience in user and stakeholder need definition; requirements definition; risk management, product architecture, reliability, and system modeling
  • The candidate must have strong analytical and communication skills.
  • BS Engineering with at least 12 years related work experience, MS Engineering with at least 10 years of related work experience, PhD Engineering with 4 years of related work experience. A minimum of BS in Electrical, Biomedical, Mechanical engineering, or a related field from an accredited college or university is required.


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.