Systems Engineer

Job Post Index 25531A-Sy##
Location Atlanta, GA
Description: Description
  • Focus on the Verification/Validation efforts of new/updated Remote Care products within the company's 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.
  • 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. This 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.
Skills: Qualifications
  • 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.
  • Verification experience required verifying against system requirements
  • 6+ years of experience
  • Regulated or Medical device experience preferred
  • Must be very process oriented
  • PTC Integrity and DOORS experience preferred
  • Defect tracking tools expertise
  • Knows how to take system requirements and can create/execute testing

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