Principal Engineer

6 days ago

Irvine, California, United States AbbVie Full time
About the Role

AbbVie is seeking a highly skilled Principal Engineer to lead the Irvine Engineering Testing & Analysis group within Combination Product Development (CPD). This is a key role with a direct impact on AbbVie's exciting and rapidly growing portfolio of combination products, with a major focus on Eye Care and Neurotoxins products.

Key Responsibilities
  • Direct project activities and professional development of a group of testing engineers by effectively mentoring, guiding and supervising personnel.
  • Serve as a technical lead on own projects while contributing engineering insights into multiple other projects.
  • Independently conceive, execute, and communicate novel multi-disciplinary approaches and development strategies that achieve project and area goals.
  • Effectively function as a principal investigator for the Lab Testing function, generating original technical ideas and strategies.
  • Generate new technical proposals and lead those efforts.
  • Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
  • Primary author of technical and regulatory documents and/or primary inventor of patents.
  • Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
  • Supervise the design and execution of experiments supporting feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
Requirements
  • A degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience.
  • Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
  • Significant background in engineering testing and analysis including direct experience of test equipment validation (IQ, OQ, PQ) is required.
  • Expertise in statistical analysis.
  • Significant documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
  • Expertise with Electronic Lab Notebooks (ELN) and Design History File tools such as Polarion/LinkUs.
  • Demonstrated effective people leadership – deliverables produced on time, and personnel development plans in effect.
  • Recognized and sought out as an expert in his/her discipline.
  • Project management competencies in budgeting (External Spend and Capital Expenditure) and resource planning as well as scheduling and tracking of project tasks.
  • Ability to manage multiple, complex projects.
  • Proficiency in MS Office, MS Project, Solidworks.
  • Lean Six Sigma, 5S experience desired.
  • Good communication skills, both written and oral. Ability to prepare technical reports and presentations.
  • Demonstrated scientific communication and presentation skills, including the ability to present to senior management.
  • Willingness and ability to travel both domestic and international up to 10% of the time.
About AbbVie

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.

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