AbbVie is looking for a Senior Systems Engineer II to join their Combination Product Development team in R&D. This individual will contribute to the development and launch of exciting new drug / device combination products. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people’s lives.
As a Senior Systems Engineer II, you will be responsible for the integration of inputs 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 to contribute 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 work across engineering teams to lead and drive the following:
- User and Stakeholder Needs Definition
- System Architecture & Integration
- Use Case Analysis
- 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 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, look for new ideas to stimulate innovation and connect unrelated concepts.
- 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.
You will be responsible to provide technical leadership in your areas of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirements.
- Leadership experience is required that includes the ability to influence and negotiate internally and externally as a part of global engineering teams.
- 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.
- Must have demonstrated technical leadership and ownership, and the ability to provide guidance and direction to less experienced technical personnel.
- 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%)
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.