Principal Engineer, Engineering Testing

3 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.


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