387 Technology Circle NW Suite 500 Atlanta GA USA 30313 Atlanta, GA 30313 US
This is a contract position for a Systems Engineer position that will primarily focus on the Verification/Validation efforts of new/updated Remote Care products within the Heart Failure division. This engineer will focus on the Verification/Validation phase of product development but may also be required to participate in the design and definition of new products. They will develop and follow specialized procedures in executing tests and document the test results to ensure the final product is ready for use by our customers. Develop working relationships with cross functional groups.
- Perform System-level Verification and Validation for product development. Includes designing and conducting system level characterization/verification of complex systems. Collect, organize, analyze, and document test results.
- Author and execute system integration and verification plans, procedures, and reports.
- Perform product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, hazard analysis, and/or design control documentation.
- Communicate effectively and participate on cross functional development teams with good negotiating skills to direct multi-disciplinary teams toward high quality solutions.
- Evaluate prototypes through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.
- Provide input into the development of clinical system validation plans and conducts those tests.
- Identifies and resolves issues and complex problems, escalating as appropriate.
- Comply 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.
- BS in Computer Science, Bio-Medical Engineering, Electrical Engineering, Systems Engineering, or Physical Science.
- Product development experience in Engineering or physical science.
- Experience in using development processes that are consistent with ISO or FDA design control standards/requirements for medical devices.
- Experience in general engineering/science principals and laboratory skills.
- Experience in one or more of the following: Electrical, mechanical, software, mathematical, chemical or biochemical technologies as they pertain to the design, integration, evaluation and commercialization of medical device systems.
- Self-starter with a desire to learn about cutting-edge heart failure treatment solutions.
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