1+ months

Systems Engineer, System Integration, Diagnostics

Santa Clara, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The Systems Integration Engineer possesses an understanding of system engineering processes and ensures that components, modules, and subsystems are successful integrated into the final hematology products. The candidate will develop studies and experiments to characterize and verify systems and participates in the development and execution of comprehensive test plans, procedures, and schedules for verifying system requirements. She/He will coordinate integrated testing activities that may include environmental, vibration, and EMC testing and perform analysis of test results including the preparation of comprehensive reports.

Job Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality system.
• Support all engineering activities related to product and process development during project phases in accordance with design controls for large, complex IVD systems.
• Select and develop integration testing techniques for ensuring the systems’ overall capability to satisfy requirements.
• Configure all necessary hardware and operating environments at the appropriate level of automation to efficiently complete all testing tasks.
• Develop test plans and test protocols; perform troubleshooting, diagnoses and resolve problems to component, module, and system level.
• Lead project phase design reviews, risk analysis, dFMEA, pFMEA.
• Demonstrate strong background in CAPA, DoE, DMAIC to develop best practices in integrated system development.
• Execute required testing for technical feasibility, system integration, verification and validation applying DFSS techniques.
• Perform calculations and engineering analyses and generate graphical representations necessary to define the new concepts developed by using scripting languages like Python, Matlab, Labview.
• Produce high quality documents and written reports, describing test-related topics in a clear and concise style and in full accordance with the organizational processes.
• Support installation maintenance and repair of internal instruments and support service activities during the development process.
• Ensure compliance to organizational policies, procedures, and quality requirements in an FDA-regulated environment.

Minimum Qualifications

Bachelor's Degree in an Engineering or closely related discipline with two to four years of related work experience or sufficient transferable experience to demonstrate functional equivalence to a degree.   Minimum 2 years’ experience.

Preferred Qualifications

• Bachelor’s degree in the field of Systems or Biomedical Engineering with 8+ years minimum direct work experience in a laboratory setting or Master’s degree with 5+ years of experience.
• Experience in Flow Cytometry and the integration with large, complex medical, IVD, and/or analytical instruments highly desired.
• Previous Design Control / Design for Six Sigma experience including experimental techniques, statistical analysis & engineering investigation techniques (DMAIC/six sigma green belt an asset).
• Strong background in CAPA, DoE, DMAIC etc. to develop best practices in integrated system development.
• Deep understanding of product requirements, risk analysis, FMEA, and quality systems.
• Excellent technical writing skills and good documentation practices.
• Knowledge of scripting languages like Python, Matlab, Labview required.
Job Family: Engineering
Division: ADD Diagnostics
Travel: No
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Systems Engineer, System Integration, Diagnostics

Santa Clara, CA

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Santa Clara, CA

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