System Engineer II

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:

Working under general supervision, performs specialized level systems engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of new algorithms or the development of specific projects. Also performs additional analysis and/or interviews to determine the requirements and constraints of various portions of the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Exercises appropriate level of technical judgment in planning, organizing, performing and coordinating clinical-systems engineering assignments. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes.

• Analyzes input requirements for medical devices, supports the instrumentation/service infrastructure, and translates these into specific system requirement/interface specifications. Participates in and contributes to the broad cross functional review of work output. Updates and maintains feature specifications in defined areas for specific projects.
• Simulates or tests aspects of new projects or algorithms to evaluate prototypes and validate output as meeting customers' intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research or bench studies. Analyzes and reports findings to immediate management.
• Investigates and defines systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through review and evaluation.
• Contributes to the evaluation and validation of a specific subsystem or project prior to submission.
• Provides input into the development of system validation plans, and the conduct of those tests.
• Interacts with functional groups as necessary to conduct feasibility studies, technology assessments, concept studies, or benchmarking studies.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

General Qualifications

• Bachelor of Science in Biomedical Engineering, Computer Science Engineering, Electronics Engineering, or related engineering field.
• Medical device industry experience preferred.
• 3-5 years of experience.

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