Device Development Engineer

Company Description

Abb Vie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose:

We are looking for experienced Development Engineer to join our Late-Stage Injection Device Development team to help us accelerate Abb Vie’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 Abb Vie’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 Abb Vie 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.

Key Responsibilities:

• Perform statistical data analysis
• Perform 3D and 2D CAD development in PDM environment
• Generation of Design Outputs such as 2D engineering drawings, subassembly specifications and purchasing specifications to be used by sourcing, clinical and commercial entities
• Working in a lab environment in support of feasibility / confidence testing, root cause analysis, and verification testing under protocol
• Experimental protocol development, documentation of results, and authoring of summary reports
• Design and fabrication of test fixtures
• Collaborating with third party developers and suppliers
• Support design transfer and industrialization activities
• Some travel required

Preferred Qualifications:

• 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
• 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

• 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.

• 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,…