Sr. Hardware Systems Engineer, Risk at Abbott (Dallas, TX)

| Dallas-Fort Worth, TX
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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 109,000 colleagues serve people in more than 160 countries.



The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Irving, TX, currently has an opportunity for Senior Hardware Systems Engineer, Risk


The Senior Systems Engineer is responsible for understanding interdisciplinary, collaborative approach to plan, design, develop the integrated set of standards, sub-standards, and assemblies needed to design and manage systems over their life cycles. Applies an interdisciplinary, collaborative approach to plan, design, develop and verify a life-cycle balanced system of systems and system/subsystems solution(s) which satisfies customer/operational needs and public/regulatory acceptability. This includes a multitude of systems requirements that range from design, development, test methodologies, validations, risk analysis, documentation, and process improvements.
  • Defines system performance (requirements and specifications)
  • Translates system level product requirements/specifications to sub-assembly specifications
  • Integrates technical parameters
  • Assures compatibility of all physical, functional and program interfaces to optimize total system of systems and/or system/subsystem architecture(s)
  • Perform specialty engineering analyses (such as affordability, safety, reliability, maintainability, testability, human systems integration, system security, regulatory, certification, and product assurance) to obtain a preferred configuration which assures product success.

  • Risk Management - Understands and applies basic Risk Management principles.
  • Maintains the risk management file including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk Reduction
  • Coordinates across functional teams in the development & execution of design risk analyses for Design Plans, Design Reviews, Design Change Requests and FMEAs
  • Performs risk assessments for Defect Tracking Support, Technical Review Boards & CAPAs
  • Participates on the Risk Management Team and establishes and maintains system risk documentation including the Risk Management Plan, Risk Management Report, Post Market Risk Assessment, Fault Tree Analysis, etc.
  • Creates and defines system requirements, system specifications and input/output process, etc. Conducts analyzes of system requirements, user needs, system design, and coordinates system evaluation activities.
  • Leads technical discussion for system level design reviews, development and testing to assess performance against design specification; reliability testing, and assessment of system interactions.
  • Provides system level technical support in developing manufacturing processes and troubleshooting issues to determine root cause and potential engineering solutions. Proactively monitors the system level health of the product and identifies potential issues.
  • Technical systems lead in documenting system requirements by writing documents, reports, memos, change requests, etc. Methods used are determined by approved procedures and standards.
  • Conducts and/or provides guidance on special studies or experiments to improve systems engineering practices, system quality, and define new components, products or processes. Independently designs and executes experiments. Utilizes DOE (Design of Experiments) as appropriate.
  • Leads moderately complex issues to determine root cause. Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving System level issues. Utilizes DMAIC and/or other investigation tools as appropriate. Teaches and mentors systematic problem-solving methodologies to other members within technical community
  • Applies process efficiency tools to improve proficiently within process and work methodologies. Collaborates with various engineering disciplines and other cross-functional groups to optimize system solutions.
  • Ensure relevant engineering knowledge and skills are up-to-date (e.g. methods and tools within software engineering, mathematics, requirements engineering, risk management, good documentation practices, product development, etc.) Clear understanding of Medical Device Regulations and quality sub-systems including Risk Management, CAPA, and Design Planning. Applies engineering/ process knowledge to support system engineering activities.
  • Leads collaboration with various technical disciplines (e.g., design, test, software, technology) through knowledge of the interaction between departments/disciplines and how their products/processes affect one another and impact non-engineering processes (e.g., Operations, Logistics, Business, Quality).
  • Provide products and services that meet the highest technical and quality standards, regulatory requirements, and company policies and processes and embrace first-time quality as a way of life - not accepting, creating or passing any defects and speaking up.
  • Monitors performance of cross-functional teams against complex timelines; develops contingency plans as needed; recommends across-site resource and strategy adjustments


  • Bachelors degree in an Engineering or closely related discipline with five or more years progressive work experience.

  • Master's Degree (e.g. Electrical, Mechanical, Computer Science, Systems Engineering) or related Engineering/Scientific Field)
  • Relevant Systems Engineering experience from any of the following types of manufacturers/industries: Medical Device, Defense/Aerospace, and/or Aviation.
  • STEM advanced degree may count towards relevant experience
  • 8 or more years' experience in the following:
  • Demonstrated experience leading complex system and risk analysis.
  • Demonstrated ability to lead and utilize data to make decisions and influence stakeholders.
  • Demonstrated success in technical proficiency, creativity, and independent thought. Experience with system level concept creation, evaluation and innovation
  • Experience with system analysis, model based system engineering and system architecture
  • Excellent verbal and written communication skills.
  • Proven Knowledge of System Engineering principles or concepts.
  • Demonstrated ability to apply principles of systems thinking to accelerate performance.


At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.


IACC Immunoassay and Clinical Chemistry

United States > Irving : LC-02





Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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More Information on Abbott
Abbott operates in the Healthtech industry. The company is located in Abbot Park, IL. Abbott was founded in 2022. It has 97838 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 245 open jobs at Abbott, click here.
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