Device Development Engineer

Role Summary

Device Development Engineer responsible for accelerating AbbVie’s injection device programs from proof-of-concept through submission and launch, working within a multi-disciplinary team at the intersection of engineering and biopharmaceuticals.

Responsibilities

• Perform statistical data analysis
• Perform 3D and 2D CAD development in PDM environment
• Generate design outputs such as 2D engineering drawings, subassembly specifications, and purchasing specifications for sourcing, clinical, and commercial entities
• Work in a lab environment to support feasibility / confidence testing, root cause analysis, and verification testing under protocol
• Develop experimental protocols, document results, and author summary reports
• Design and fabricate test fixtures
• Collaborate 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

Preferred

• 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