Purpose:

We are looking for an experienced and versatile Senior Scientist II/Mechanical Engineer to join our Injection Device Development team to help us accelerate AbbVie’s combination products from proof-of-concept through submission, industrialization and launch. 

Our team has end-to-end accountability for commercial development, submission, industrialization and marketed product support for injection devices that enable the delivery of AbbVie’s innovative medicines. In the course of our work, we collaborate with early-stage CMC, Quality Assurance, Regulatory Affairs, Internal and External Manufacturing, and other cross-functional colleagues to ensure timeliness, robustness and market success.  

As a Senior Scientist II/Mechanical Engineer at AbbVie you will be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. The problems you would help to solve relate not only to the function of innovative injection systems, but also the way in which they interact with drug products and the human body. You would be responsible for advancing programs that combine proven delivery systems with viable commercial drug assets. If you are a self-motivated person who thrives on solving complex problems and are excited by the idea of putting life-changing therapies in the hands of patients, this might be the opportunity for you. 

Key Responsibilities:  

• Create and maintain product design documentation 

• Lead design transfer and industrialization activities 

• Initiate and lead product design changes and continuous improvement effort 

• Design and execute laboratory studies supporting product development and on-market investigations 

• Conduct analytical modeling of key performance attributes of designs 

• Perform 3D and 2D CAD development in PDM environment 

• Protocol development, documentation of results and authoring of summary reports  

• Collaborating with third party developers and suppliers 

• Position required up to 25% of travel time  

Preferred Qualifications:  

• BS in Mechanical or Biomedical Engineering (MS preferred, PhD aspirational) 

• 10-12 years of experience (MS 8-10 years, PhD 2-4 years) ideally in the medical device, drug delivery or other regulated industry  

• Strong communication skills (both written and verbal) 

• Strong design and analytical skills 

• Experience with: 

• Design controls (in accordance with ISO 13485 / CFR 820.30) 

• High volume manufacturing processes 

• 3D CAD modeling, detailed engineering drawings, product database management environment and GD&T 

• Laboratory environment, experiment planning, material control and recordkeeping 

• Technical protocol and report writing 

• Statistical analysis  

• Physical prototyping (including 3D printing, manual machining, etc) 

• Toolroom environment 

• Knowledge of material properties, material selection and testing methodologies 

• The ability to create and manage schedules for sub-tasks and work streams for which you are responsible 

• A keen eye for identifying project risks and proactively developing mitigation plans