Principal Engineer

Purpose

AbbVie is looking for a Principal Engineer to lead the Irvine Engineering Testing & Support (ETS) team within Combination Product Development (CPD).

Direct project activities and professional development of a group of testing engineers by effectively mentoring, guiding and/or supervising personnel. Independently conceive, execute, and communicate novel multi-disciplinary approaches and development strategies that achieve project and area goals. Serve as Technical Lead on his/her own project and contribute engineering insights into multiple other projects.

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.

Responsibilities

• Effectively function as a principal investigator for the Lab Testing function, generating original technical ideas and strategies.

• Demonstrate creative 'out of the box' thinking to solve difficult problems and champion new technologies to achieve project goals.

• Make significant contributions to multiple project teams.

• 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.

• Recognized and sought out as an expert in his/her discipline within the company and possibly externally.

• 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.

Contribute directly to technical activities, including:

• Establish and maintain lab equipment/software capabilities by authoring SOPs and qualification packages, developing training, troubleshooting issues, and leading audit reviews.
• Define, develop, and validate/transfer test methods.
• Create verification plans, protocols, records, and reports. Support investigations and issue resolutions. Coordinate testing across multiple test executors and manage test schedules.
• Analyze, document, and present results to cross-functional teams. Independently conceive, execute and communicate novel multi-disciplinary development strategies that achieve project and group goals. Ensure scientific insights are leveraged across projects.
• Stimulate innovation and foster an inclusive and collegial work environment.
• Serve as Technical Lead on one or more development projects

Education and Experience

• 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.

• Demonstrated effective people leadership – deliverables produced on time, and personnel development plans in effect.

• 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

• Recognized and sought out as an expert in his/her discipline within the company and externally.

• Expertise in statistical analysis.

• Direct experience of test equipment validation (IQ, OQ, PQ) is required.

• Project management competencies in budgeting (External Spend and Capital Expenditure) and resource planning.

• Creation of schedules and tracking of tasks to these schedules.

• Proficiency in MS Office, MS Project, Solidworks

• Lean Six Sigma, 5S experience desired.

• Can hire at Associate Director Level or Principal Engineer level depending on experience

Essential Skills and Abilities

• Experienced in people & R&D Lab management
• Engineering testing and analysis
•  Equipment validation, method development, statistical analysis
•  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.
•  Ability to manage people, both performance and development aspects, effective mentoring of junior engineers.
•  Ability to manage multiple, complex projects.
•  Ability to operate and drive GLP requirements for device and packaging laboratory. ·
• Strong analytical skills to support internal decision making as well as successful interfacing with 3rd party vendors.
•  Able to work with cross functional teams including R&D, Manufacturing, Marketing, Regulatory, etc.
• Ability to assess technical opportunities as needed and to make appropriate assessments and recommendations to management.
• Willingness and ability to travel both domestic and international up to 10% of the time.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.