AbbVie is looking for a R&D Development Engineer II to join our Device Development team to serve as a Device Engineer to support pipeline and development 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.

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 Product Development Engineer, you would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. This role will be working closely with device technical lead and SMEs to support and lead sub system level activities of innovative drug delivery devices including electromechanical, Mechanical, Prefilled Syringes for various therapies. 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.

Responsibilities:

• Highly autonomous and productive in performing in designing, prototyping, test method development, fixture development, laboratory research, requiring only minimal direction from or interaction with supervisor.
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• Routinely demonstrate engineering initiative and creativity in research or development activities.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Lead specification, drawings, design control deliverables including protocol and reports.
• Executing feasibility and engineering confidence tests to determine design viability and margin
• Maintain a high level of productivity in the lab and/or pilot plant.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug, and radioactive compounds, GxP compliance, and animal care where applicable.
• Provide mentorship to junior staff members.

Qualifications:

• BS in Mechanical Engineering or equivalent related engineering education and extensive, typically 7+ years of experience; MS or equivalent education with typically 5+ years of experience.
• Experience in developing sub system or components for mechanical, electromechanical, and pre-filled syringes/cartridges medical devices, preferably in the drug delivery space.
• Working knowledge of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971).
• Working knowledge of developing test method, Design verification, Equipment validation & descriptive statistics.
• Intermediate proficiency with 3D CAD modeling, detailed engineering drawings, and GD&T.
• Ability to lead or co-lead design development project tasks and deliverables across multidisciplinary functions.
• Clear and concise written and verbal communication while working cross functionally without direct authority.
• Support identifying project risks and proactively developing mitigation plans.
• Ability to prioritize and adapt in rapidly changing environment and stakeholders need.
• SolidWorks Professional and Design for Six Sigma experience is desired

• 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.

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.

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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.

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