Senior Device Development Engineer

AbbVie•North Chicago, IL

16h•Onsite

About The Position

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. They 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 their Allergan Aesthetics portfolio. The company is looking for an experienced Development Engineer to join their Late-Stage Injection Device Development team to accelerate AbbVie’s combination products from proof-of-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 innovative medicines. This role involves collaboration 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, the individual would be part of a multi-disciplinary team working 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. The role is responsible for advancing programs that combine proven delivery systems with viable commercial drug assets. It is suited for a self-motivated person who thrives on solving complex problems and is excited by the idea of putting life-changing therapies in the hands of patients.

Requirements

Bachelor’s Degree or equivalent education and typically 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, OR PhD and typically 4 years of experience
BS in Mechanical or Biomedical Engineering
Possess thorough theoretical and practical understanding of own scientific discipline
Effective writer and communicator of research or other regulatory materials
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)
Experience with Physical prototyping (including 3D printing, manual machining, etc.)
Experience with 3D CAD modeling, detailed engineering drawings, and GD&T
Experience with Experimental protocol development, documentation of results, and authoring of summary reports
Experience with Statistical data analysis
Knowledge of material properties, material selection and manufacturing processes
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

Nice To Haves

MS in Mechanical or Biomedical Engineering

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