Systems Engineer Consultant I #JN -122020-58353

Bothell, Washington
Industry: Admin/Networking/System Engineer
Job Number: JN -122020-58353

Experience:

  • Minimum 8 years professional experience in the applicable role

Education:

  • Bachelor's /Master's degree in Engineering. Demonstrated capability and experience in role

Description:

  • Skilled in evaluation, application, synthesis, decision making, reliability engineering, and project management. Familiar with the Systems Engineering Lifecycle with knowledge of requirements analysis; design of systems architectures and high-level designs; delivering technical presentations; system components and applications; designing for reliability in medical devices, and interfacing with third party hardware and software vendors
  • Systems Engineering position that covers a broad range of capabilities including market research, requirement generation, system requirement generation, requirements decomposition, Risk Management, design analysis, test planning, test procedure development, verification & validation, and certification
  • Conducts root cause investigation, corrective action determination and deployment, containment activities, and all other activities related to the Corrective Action/Preventive Action (CAPA) process. Experienced in providing systems engineering solutions for technical programs that are subject to Government regulation and familiar with applicable Government and ISO standards
  • Medical device background preferred. Reliability engineering experience preferred. Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 62304, IEC 60601-2-4, and/or IEC 60601-1-2. DOORS Next Gen experience preferred



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