System Engineer

3 weeks ago


Pittsburgh, United States Intellectt Inc Full time

Title: Sr. Systems Engineer

Location: Pittsburg, PA

Visa: Any Visa


Job Description:

Mandatory Skills:

  • Systems Engineering for Electromechanical Medical Devices, InCose certification ISO 13485, ISO 14971, IEC 62304, Usability for Medical devices, Regulatory for Medical Devices Requirements Management, Jira, IEC 60601-1 and any Particular standards.
  • Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance.
  • Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification
  • System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability.
  • Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews.
  • Ensuring full Product Safety Risk Management in a regulation compliant manner KPI


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