Principal Engineer Device Development

We are looking for a Principal Research Scientist I 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 work closely with crossfunctional colleagues in operation as programs transition to commercial development. These devices enable the delivery of innovative medicines targeted at difficulttocure diseases with the goal of making a remarkable impact on peoples lives.

The Principal Engineer will work within the Product Engineering group which is responsible for developing products based on user needs and product requirements completing device design specification conducting feasibility assessments through prototyping and lab testing and supporting design and verification activities to create robust devices.

As a Principal Product Development 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.

The position is based in Irvine CA USA and may require domestic and international travel as needed (up to 15 domestic and international).

• Serve as the Principal Investigator Device Lead and Device Subject Matter Expert generating original technical ideas and developing research or development strategies.
• Drive the design process ensuring robust reliable and userfriendly products through partnerships.
• Be recognized and sought out as an expert in the field effectively leading crossfunctional device development teams through feasibility design control phases and life cycle management.
• Oversee the development of devices for design verification and validation. Work closely with the development partners and manufacturers to ensure design feasibility and reliability
• Provide technical expertise and mentorship for the organization. Foster a collaborative environment to promote innovation and problemsolving.
• Conduct feasibility assessment of different device solutions including early prototyping analysis and lab testing.
• Support assembly process development for integrated combination products
• Provide support for design verification (test method development issue resolution)
• Perform root cause analysis and corrective action when required
• Maintain comprehensive documentation of design processes specifications and test results. Ensure compliance with quality management systems and regulatory bodies.
• Work with software electrical and systems engineering teams as well as quality assurance and regulatory affairs to ensure seamless product integration.
• Stay abreast of industry trends new technologies and regulatory changes. Implement best practices for mechanical design and development.
• Conduct feasibility and engineering confidence tests to assess design viability and margins.
• Plan and manage Design Inputs/Outputs oversee Design Reviews and lead Design Verification strategies including test method development and issue resolution.
• Perform analytical modeling of key performance attributes.
• Collaborate with external global manufacturing and development partners.
• Provide mentorship to a team of one or more individuals on own and other projects. This role may have direct supervisory responsibility of one or more individuals and is accountable for the effective performance of the team/individuals.

Qualifications :

• BS in Biomedical or Mechanical Engineering or equivalent related engineering education with extensive experience 14 years); MS with 12 years of experience; or PhD with 6 years in the
• relevant scientific discipline.
• Experience in developing mechanical electromechanical and prefilled syringes/cartridges for medical devices preferably in the drug delivery space.
• Detailed understanding of Design Controls (CFR 820.30 / ISO 13485 and Risk Management (ISO
• 14971 principles and practices.
• Experience with physics principles such as fluid mechanics and thermodynamics and familiarity with material science and polymer chemistry related to drug delivery devices.
• Demonstrated expertise in computational analysis (e.g. FEA system modeling) and descriptive statistics.
• High proficiency in 3D CAD modeling creating detailed engineering drawings and applying GD&T.
• Ability to drive large complex design development projects across multidisciplinary functions.
• Clear concise written and verbal communication skills for effective crossfunctional collaboration with or without direct authority.
• A keen eye for identifying project risks and proactively developing mitigation plans.
• Ability to prioritize and adapt in a rapidly changing environment and meet stakeholders needs;
• Design for Six Sigma experience is desired.

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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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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