AbbVie is looking for a 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 Systems Engineer at AbbVie, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance.
You will be responsible to understand and implement appropriate product development engineering principles within AbbVie. It is expected that the engineering activities for which you will be responsible may be done internally and externally. The system engineering role works closely with internal stakeholders from Commercial, Operations, Quality, and R&D to help define and drive critical drug delivery projects within AbbVie. The external engineering activities will require you to develop and foster relationships with external Engineering Services firms and third-party development partners who may be located in Europe, India, Asia, and US, and in addition to regular WebEx/teleconferences, will require periodic face-to-face visits. You will be responsible to provide technical leadership in your area’s of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirements.
- 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 desired with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, ISO 13485 and MDR preferred.
- Experience is required in user and stakeholder need definition; requirements gathering, requirements definition (includes standards decomposition), and traceability; risk management (ISO 14971), system architecture, reliability, verification and validation of medical devices or combination products.
- Experience working with requirements management tools such as Doors and/or Polarion is preferred.
- Experience developing platforms (ie platform dhf – common sets of requirements that can be applied to a single device platform) preferred.
- The candidate must have strong communication and influencing skills, the ability to find the way forward through ambiguity, and solid decision-making skills. It is expected that you 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 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 is desired.
- Travel will be required, as necessary. (10%)
- BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
- Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
- Demonstrated ability to learn, understand and master new experimental techniques.
- Ability to multitask and work within timelines.
- Demonstrated scientific writing skills and strong verbal communication skills.