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Qualification: BE/B Tech or Equivalent
Experience range: 7 to 10 years
Experience:
Needs general systems engineering background/expertise for requirements management, safety risk assessments, FMEAs, trace matrices. Biocompatibility experience per ISO 10993 would be a big plus. V&V background could also be helpful.
Responsibilities:
Expert and technical lead with proven experience. Skilled in evaluation, application, synthesis, decision making, and project management. Expert in the Systems Engineering Lifecycle with in-depth knowledge of requirements analysis; design of systems architectures and high level designs; delivering technical presentations to various management levels; system components and applications; and interfacing with third party hardware and software vendors. Systems Engineering position that covers a broad range of capabilities including market research, requirements generation, requirements decomposition and traceability, Safety 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. 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.
Intellectt INC
