AbbVie is looking for a Principal Development Engineer I/II to lead a team of engineers within our Device Development organization. The Principal Engineer will lead and guide multidisciplinary device pipeline and development projects while driving the overall performance of the team. 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.
Within Device Development, the Product Engineering group is responsible for developing products informed by user needs and product requirements, completing feasibility assessments involving prototyping and lab testing, and ultimately supporting design and verification activities that result in robust devices. These devices 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.
As a Principal Product 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 drug delivery devices including electromechanical, Mechanical, Prefilled Syringes for various therapies, but also the way in which they interact with drug products and the end customers and users. If you are a self-motivated person who thrives on solving complex problems and are excited by the idea of taking on the toughest health challenges, this opportunity is the right fit for you.
The position is based in Irvine, CA, US. Domestic and International travel may be required, as necessary. (Up to 25%).

QUALIFICATIONS

Job level will be commensurate with experience.

• BS Mechanical Engineering or equivalent related engineering 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 in area or scientific area of discipline.
• Experience developing a range of mechanical, electromechanical, and pre-filled syringes/cartridges for medical devices, preferably in the drug delivery space.
• Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971)
• Demonstrated expertise in computational analysis (FEA, system modeling, etc) and descriptive statistics.
• High level of proficiency with 3D CAD modeling, detailed engineering drawings, and GD&T.
• Ability to drive large complex design development projects across multidisciplinary function.
• Clear and concise written and verbal communication while working cross functionally with/without direct authority.
• A keen eye for identifying project risks and proactively developing mitigation plan.
• Ability to prioritize and adapt in rapidly changing environment and stakeholders need
• Design for Six Sigma experience is desired
• Recognized and sought out as an expert in her/his field.

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.

LI-Onsite

AbbVie 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

• Effectively function as a principal investigator, Device technical lead, generating original technical ideas and research or development strategies.
• Provide mentorship to a team while leading projects. This role will have direct supervisory responsibility and be accountable for the effective performance of the team.
• Effectively lead cross functional device development team through feasibility, design control phases and life cycle management.
• Develop robust device design development strategies and execute successful implementation for the clinical and commercial release globally.
• Lead and support device technology landscaping and early-stage definitition.
• Executing feasibility and engineering confidence tests to determine design viability and margin
• Design Inputs/Outputs planning and ownership of Design Reviews
• Lead Design Verification strategy, & support execution including test method development, issue resolution.
• Analytical modeling of key performance attributes.
• Collaborating with external global manufacturing and development partners