Senior Mechanical Engineer, Devices and Combination Product

Company Description

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 Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

We are looking for a Senior Mechanical Engineer to join our Devices and Combination Product Development team in R&D. This individual will contribute to the development of exciting new drug / device combination products for various phases of clinical studies and will work closely with cross-functional colleagues in operation as programs transition to commercial development. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people's lives.

Within the Devices and Combination Product Development team in R&D, the Product Engineering group is responsible for developing products informed by user needs and product requirements, conducting feasibility assessments involving prototyping and lab testing, completing device design specification, and supporting design and verification activities that result in robust devices.

As a Senior Mechanical Engineer, you will be part of a multidisciplinary team operating at the intersection of engineering and biopharmaceuticals. You will be working with a global team of exceptional scientists and engineers on a variety of drug delivery systems from syringes to autoinjectors to complex electromechanical pumps. Your role will also involve interactions with CMC drug products, analytical efforts, regulatory requirements, quality standards, operations, external customers, users, contract manufacturing, and suppliers. Your expertise and leadership will ensure the delivery systems are safe and effective in meeting their intended use for clinical and commercial development programs.

Responsibilities:

• Serve as the Device Subject Matter Expert, generating original technical ideas and developing research or development strategies.
• Drive the design process, ensuring robust, reliable, and user-friendly products through partnerships.
• Provide technical expertise and mentorship for the organization. Foster a collaborative environment to promote innovation and problem-solving.
• Conduct feasibility assessment of different device solutions, including early prototyping, analysis, and lab testing.
• Definition and execution of engineering confidence test plans and design margin assessment
• Design Outputs planning and ownership of Design Output Reviews
• Support of delivery system reliability
• Provide support for design verification (test method development, issue resolution)
• Perform root cause analysis and corrective action when required
• First principles analysis and modeling of key performance attributes
• Maintain comprehensive documentation of design processes, specifications, and test results. Ensure compliance with quality management systems and regulatory bodies.
• 3D CAD development
• Generation of Design Outputs such as 2D engineering drawings, subassembly specifications and purchasing specifications to be used by sourcing, clinical and commercial entities
• Collaborating with external global manufacturing and development partners
• Some travel required

Qualifications

• BS in Mechanical Engineering with 12+ years of experience, ideally in the medical device and / or pharmaceutical industries; MS with 10+ years of experience; or PhD with 4+ years of experience
• Experience developing a range of mechanical and electromechanical 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)
• Strong device design and analytical skills

Additional Information

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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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