Principal Engineer, Combination Product Development

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Principal Engineer in the Combination Product Development is recognized as a technical expert for plastic injection molded part design, injection molding, and/or material science. She/he is skilled with engineering tools like CAD, FEA, statistical and data analysis.
Responsibilities include:
• Design, development and coordination of cross-functional teams in development of drug delivery systems for the pharmaceutical, biological, eye care, and medical aesthetics businesses. Applies sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects. Executes and supervises scientific studies and manages laboratory activities. Manages the development of test methods, policies, and standards for the department.
• Assures compliance with regulatory requirements for both domestic and international markets and is an effective contributor to CMC teams. Works with regulatory leads to meet worldwide registration requirements.
• Position interfaces with other AbbVie functions such as: Operations, Marketing, Regulatory Affairs, Quality Assurance and Clinical.
• Additional responsibilities may encompass direct or indirect supervision and training of exempt and non-exempt technical personnel.
• Responsibilities may require recommendation and control of capital expenditures as defined in the capital appropriation budget.
• Develops and maintains a current in-depth knowledge of global regulatory submission requirements, GLP/GMP requirements and maintains up to date knowledge of state-of-the-art solutions and device development strategies though trade journals, seminars, and trade shows.
• Represents department in project team meetings and works closely with other Pharmaceutical Development groups, Microbiology, Regulatory Affairs, Project Management, Manufacturing, Quality Control, and Marketing to meet project timelines and objectives. May lead Device Development sub-team for one or more development projects.
• Oversight of external partners; manages vendors and CMO's in both development of new products, and manufacturing activities.

Qualifications

Education and Experience:

• B.S. Degree in Plastics, Materials, or Mechanical Engineering with minimum 10 years of experience, or an advanced degree with minimum 8 years of experience with combination product development in the Pharmaceutical field preferred; pure device development experience will be considered as well.
• Advanced classes in subject field preferred.
• Experienced in design for plastic injection molded products, catheter design, and development of associated products in pharmaceuticals and biologics programs.
• Working knowledge of Design Controls and Risk Management methodologies and their application to combination products from a device and packaging perspective.
• Demonstrable track record of achievement in device development and materials selection, through criteria evaluation, validation, and implementation.
• Experience with Design for Manufacture and scalability.
• Working knowledge of DoE and other statistical tools.
• Experience in direct supervision and training of technical staff a plus.

Essential Skills and Abilities:

• A team attitude with positive outlook is a must.
• Able to work with cross functional teams including R & D, Manufacturing, Marketing, Regulatory, etc.
• Ability to manage multiple, complex projects.
• Proactively assess/identify new opportunities to enhance impact of device development on cross-functional projects and teams.
• Ability to assess technical opportunities as needed and to make appropriate assessments and recommendations to management.
• Support of Manufacturing in troubleshooting production problems.
• Project management competencies in budgeting and resource planning.
• Creation of schedules and tracking of tasks to these schedules.
• Good communication skills, both written and oral. Ability to prepare technical reports and presentations.
• Willingness and ability to travel both domestic and international up to 25% of the time.
• Proficiency in MS Office and project management programs, as well as engineering packages Solidworks, Minitab, and Matlab.

Travel
Yes, 25 % of the Time

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.