Principal Device Development Engineer

Company Description

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

We are looking for an experienced Principal Device Development Engineer to join our Late Stage Injectables Development team and lead the acceleration of AbbVie's combination products from proof-of-concept to submission and launch.

Our team is responsible for leveraging proven device platforms to enable the delivery of AbbVie's innovative medicines targeted at difficult-to-cure diseases, with the goal of making a remarkable impact on people's lives. In doing so we work with early-stage CMC, Quality Assurance, Regulatory Affairs, Operations Industrialization and many other cross-functional colleagues to ensure timeliness, robustness and market success.

As a Principal Development Engineer 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 subcutaneous injection systems, but also the way in which they interact with drug products and the human body. You would be responsible for leading late-stage combination product development 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 opportunity might be for you.

Responsibilities:

• Supporting creation and execution of development partner contracts
• Collaborating with external global manufacturing and development partners
• Detailed workstream planning (strategy, timing and confidence level) in support of Program Management team
• Definition and leadership of engineering confidence test plans
• Design margin assessment using experimental and predictive modeling methods
• Leading creation of key Design History File documentation (Design and Development Plan, etc)
• Design Outputs planning and ownership of Design Output Reviews
• Supporting the transfer of finalized Design Outputs to the Industrialization and on-market teams
• Support of delivery system reliability activities (shelf life / stability and device performance)
• Design Verification support (test method development, issue resolution)
• Root cause analysis and corrective action
• Some travel required

Qualifications

• MS in Engineering (ideally mechanical or biomedical; BS considered with commensurate experience)
• 12-18 years of development experience including a substantial portion in the medical device and / or pharmaceutical industries
• Experience developing a range of mechanical and electromechanical devices, preferably in the drug delivery / pharmaceutical space
• Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971)
• Strong communication skills (both written and verbal), analytical and critical thinking
• Strong analytical and critical thinking skills
• Experience with a wide range of laboratory testing equipment and methods (force-displacement testing, gravimetric methods, high speed videography, data logging systems, etc)
• Proficiency with 3D CAD modeling, detailed engineering drawings, and GD&T
• Knowledge of material properties, material selection and manufacturing processes
• Working understanding of computational analysis (FEA, system modeling, etc)
• Proficiency in tolerance analysis and descriptive statistics
• A keen eye for identifying project risks and proactively developing mitigation plans

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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 short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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