Senior Device Development Engineer

Development Engineer

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.

We are looking for an experienced Development Engineer to join our Late-Stage Injection Device Development team to help us accelerate AbbVie's combination products from proof-of-concept through submission 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 Development Engineer at AbbVie you would 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.

Responsibilities:

• Create and maintain product design documentation such as 2D engineering drawings, subassembly specifications and purchasing specifications to be used by sourcing, clinical and commercial entities
• Perform 3D and 2D CAD development in PDM environment
• Design and execute laboratory studies supporting product development such as feasibility/confidence testing, root cause analysis, and verification testing under protocol
• Design and fabrication of test fixtures
• Conduct analytical modeling of key performance attributes of designs
• Collaborating with third party developers and suppliers
• Support design transfer and industrialization activities
• Some travel required

Preferred Qualifications:

• BS in Mechanical or Biomedical Engineering (MS preferred)
• 10-12 years of experience, 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)
  • Physical prototyping (including 3D printing, manual machining, etc.)
  • 3D CAD modeling, detailed engineering drawings, and GD&T
  • Experimental protocol development, documentation of results, and authoring of summary reports
  • Statistical data analysis
• Knowledge of material properties, material selection and manufacturing processes
• 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

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.

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

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.

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Pay Range: $109500 - 208500 USD

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.