Principal Mechanical Engineer

JOB DESCRIPTION:

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

The Opportunity

Our diagnostic solutions are used in hospitals laboratories and clinics around the globe. The crucial information derived from our tests instruments and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

The Principal Mechanical Engineer will be based at our Irving TX site and support our Core Lab team part of our Diagnostics division. They are responsible for independently performing and overseeing tasks related to the execution of new and existing products processes prototypes fixtures and tools. Apply advanced multidisciplinary engineering knowledge to design and develop innovative medical devices and complex subsystems in support of business strategies. Provide broad technical leadership and effective engineering solutions in area of expertise. Executes continuous quality improvement and is the technical lead for subsystem and/or instrument projects. Provides training and/or mentorship to other engineers.

Main Responsibilities

• Leads the development of designs for new and existing systems in accordance with applicable procedures and medical regulatory standards performs analysis on design concepts and tests theories to reduce risks.
• Establish requirements and specifications for medical devices (including justifications and supportive testing).
• Demonstrated success in the ability to specify design verify and validate new medical devices to meet user needs.
• Uses extensive understanding of processes used in design and manufacturing to develop and execute new medical devices processes equipment materials verification and validation.
• Uses experimental empirical and numerical analyses to evaluate designs.
• Performs engineering analysis with simulation tools to mitigate design risks and ensure new design reliability.
• Leads test method and simulation model development.
• Assists in the development of site engineering and technical guidance and standards.
• Establishes technical competence. Identify and mitigate project and site product line risks.
• Leads the development of product specifications FMEAs DOEs verification and validation protocols and plans.
• Recommend and implement Design Control procedures for development in accordance with FDA guidelines.
• Recommend improvements to Design Control and other quality process and procedures.
• Applies theoretical principles evaluation ingenuity and creative / analytical techniques for assessment across sub-system level designs.
• Apply advanced troubleshooting and root cause analysis (RCA) tools and techniques to troubleshoot multiple sub-system designs.
• Provides written technical justifications and rationale for multiple sub-system designs.
• Manages risk management documentation including dFMEA pFMEA and risk analyses. Identifies and mitigates design risks for multiple sub-systems.
• Use knowledge of engineering and cross-functional tasks and establishes overall engineering schedule.
• Achieves engineering tasks per established timelines.
• Provides ideas for process improvements that drive engineering task efficiencies.
• Develops products processes and/or design tools to be employed for investigation and design development within organization.

Education and Experience

Required

• Degree in Mechanical Engineering (or closely related STEM field)
• Minimum 10 years of relevant experience
• Demonstrated strong leadership within an Engineering and Project teams
• Demonstrated ability to multi-task across multiple projects in various stages of development.
• Demonstrated high proficiency with Solidworks.

Preferred

• Proficiency with Siemens Team Center (APLM) and Solutions Business Manager (SBM)
• Understands aspects of Design / Change Control: Design Planning CR creation/workflow and ability to write Description/Reason/Justification (DRJ) statements in support of drawing releases.
• Strong Project Management and workload organization skills.
• May include limited travel including international.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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