Senior System Design Engineer

SENIOR SYSTEM DESIGN ENGINEER - Abbott Laboratories / Irving, TX

Lead the development of designs for new and existing subsystems of medical devices in accordance with applicable procedures and medical regulatory standards, including FDA 21 CFR 820 and ISO 13485. Perform analysis on design concepts, and tests theories to reduce risks. Utilize empirical, numerical and experimental analysis to analyze designs. Design, develop, and specify new hardware features or improve existing hardware features. Specify, design, verify, and validate appropriate materials, components, processes, and technologies for subsystems and related supply chain and purchasing activities. Develop Quality System Requirements (QSR) document to release Production Candidate Service Bulletin instructions and facilitate upgrade of instrument configurations. Develop and maintain PCSB instructions and documentation for Verification Prototype instruments and support streamlined production workflows. Manage change control processes for engineering projects, ensuring all modifications were properly documented and approved. Track upgrades and rework for instruments, ensuring each instrument is maintained at the required configurations. Conduct regular configuration audits to verify compliance with established standards and identify areas for improvement. Manage cable configurations and collaborate closely with electrical engineers to ensure seamless integration. Implement cost reduction strategies in design and development, optimizing resource use and reducing expenses. Track and record all configuration changes through RSLMS system. Lead cross-functional team meetings to ensure adherence to design timelines. Implement configuration management practices, including version control, change tracking, and documentation updates, to maintain accuracy and traceability throughout the design and development lifecycle.

Bachelors or foreign equivalent degree in Engineering, Computer Science, Information Systems, or in a related field of study with least 5 years of related progressive professional experience. In the alternative, will accept a Masters or foreign equivalent degree in Computer Science, Information Systems, Engineering, or in a related field of study with at least 3 years of related professional experience. Must possess experience in: (i) development of designs for new and existing subsystems of medical devices in accordance with applicable medical regulatory standards, including FDA 21 CFR 820 and ISO 13485; (ii) utilizing empirical, numerical and experimental analysis to analyze designs; (iii) specifying, designing, verifying, and validating appropriate materials, components, processes, and technologies for subsystems and related supply chain and purchasing activities; and (iv) implementing configuration management practices, including version control, change tracking, and documentation updates, to maintain accuracy and traceability. Employer will accept any suitable combination of education, training, or experience.

An EOE. 40 hrs/wk. Send resumes to: Abbott Laboratories, Elvia Salazar, Willis Tower, 233 S. Wacker Dr. Floor 25, Dept. 32, Chicago, IL 60606. Ref to ad code: ABT-0101-ES.