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Systems Engineer
Ref No.: 17-01047
Location: Baltimore, Maryland
Position: Systems Engineer
Location: Baltimore, MD
Contract: 1 Year

Qualifications:
Familiarity with FDA regulations for Medical Instruments, ISO 14971, IEC 62304 standards.
• Familiarity with Design for Six Sigma Required:
• Four Years Undergraduate degree preferably in Engineering or Science
• 2-5 Years of Software / System Verification & Validation experience preferably in an embedded/ hardware environment.
• Familiarity with Defect Tracking Tools, Requirement Management and Test Management Tools such as TFS, Client ALM (Quality Center), Cognition Cockpit.
-Strong Interpersonal skills to work in a cross functional team to complete Testing Tasks as per Project's and Client's quality needs and timelines
• Proven and creative Test skills with attention to details. Thinks out-of-box to Client product anomalies and helps improve the test efficiencies and effectiveness
• Familiar with Industry standard processes of Software and System development cycles. Understands specifications and requirements to create Test Protocols and Test Cases to provide optimal test coverage and speed of execution.
• Understands Corrective Action and Preventive Action (CAPA) processes.
• Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.

Responsibilities:
Provides Testing support to Sustaining activities
Executes planned Test cases to Client functional and nonfunctional System and Software anomalies with Risk impacts
• Provides a detailed description of discovered anomalies to obtain resolutions from Software, System, Electrical and Mechanical Engineering teams
• Supports Service/Training organization for troubleshooting customer complaints, Supports Software, Systems and Engineering Teams with Trouble shooting, Characterization and Validation activities for Prototypes, Breadboards and Sub-Systems .