Device Development Engineer

Role Summary

Device Development Engineer role at AbbVie. We are seeking an experienced Development Engineer to join our Late-Stage Injection Device Development team to accelerate AbbVie’s combination products from concept through submission and launch. The 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 medicines. You would work with cross-functional colleagues to ensure timeliness, robustness and market success. As a Development Engineer you would be part of a multi-disciplinary team at the intersection of engineering and biopharmaceuticals, solving problems related to the function of innovative injection systems and their interaction with drug products and the human body. You would advance programs that combine proven delivery systems with viable commercial drug assets. If you are self-motivated, thrive on solving complex problems, and are excited by putting life-changing therapies in the hands of patients, this might be the opportunity for you.

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

Qualifications

• 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.

Skills

• 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