Principal Preclinical Engineer

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Position Summary:

We are recruiting for a Principal Preclinical Engineer to join our team.  This position will be located in Plymouth, MN.  In this role, you will function as the preclinical project leader for the Structural Interventions business unit within Abbott’s Structural Heart Medical Device Division.  You will be responsible for managing all pre-clinical study activities including, ensuring the availability of the proper devices and equipment to successfully conduct the study, determining study schedule and objectives, and ensuring all aspect of the data collected meets the protocol requirements and expected scientific practices.

Primary Responsibilities:

• Manage preclinical animal research studies (GLP and non-GLP) that evaluate the safety and efficacy of Abbott's Structural Heart medical products. 
• Partner with the Structural Interventions development teams in developing and executing preclinical test plans to evaluate new medical devices.  This includes study designs, protocols, and final reports.
• Determine and/or develop the best preclinical models to be used with the various medical devices that are being developed
• Partner with project teams to provide expertise in the development of anatomically accurate bench models for evaluating new product designs.  This may include evaluation of CT, flouroscopy, and/or echo images to determine appropriate anatomical conditions. 
• Ensuring compliance to all applicable regulations in the execution of preclinical studies
• Partners with other scientists, researchers and engineers in the development of study designs, protocols, and final reports
• Contributes to overall preclinical strategy for the Structural Interventions team
• Serves as the single point of study control and is ultimately responsible for the compliance of the study to Good Laboratory Practices, the Animal Welfare Act, and all other applicable regulations.
• Interfaces with quality assurance, regulatory committees (e.g. IACUC), and Regulatory Affairs regarding requirements and results of the study.
• Reviews preclinical study data intended for regulatory submissions for compliance to Good Laboratories Practices.
• Researches and develops appropriate animal models that will meet the needs of the studies and research goals.
• Responsible for coordinating contracts and billing with preclinical facilities used for conducting animal studies.
• Assists in planning of budget and study/project schedule in meeting group business goals.
• Limited travel may be required including attending out of town meetings/conferences and performing preclinical studies at non-local sites if determined to be appropriate.

Required Qualifications

• Bachelor's Degree in Engineering, Biological Sciences or other related technical or scientific discipline
• 7+ years of experience in a preclinical, animal study environment and/or running preclinical animal studies
• Demonstrated experience in design, protocol development, coordination, analysis and documentation of preclinical studies
• Proven ability to critically evaluate study-related documentation and correspondence and to clearly document and communicate plans and results.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Proficiency in MS Office Suite including Word, Excel, and PowerPoint
• Knowledge of regulations regarding medical device development and the utilization of live animals

Preferred Qualifications:

• Advanced level of degree(s) in Engineering, Biological Sciences or other related technical or scientific discipline
• Working knowledge of invoicing/accounting/contract management
• Previous leadership/management experience

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