Systems Engineer

3 weeks ago


Cleveland, United States Research Group Full time
Job DescriptionJob DescriptionJob Description

Responsibilities

 

  • Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.
  • Develops/maintains system architecture and interface requirements for the products, based on technology and platform strategies.
  • Defines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.
  • Implements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements.
  • Responsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.
  • Develops/maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC 60601-1 and its appropriate subparts.
  • Works with other team members and functions to execute design reviews of complex Medical Devices.
  • Drives structural design documentation and plans by applying engineering best practices.
  • Conducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.
  • Effectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.
  • Understands and follows quality and product development processes.
Qualifications

Requirements

 

  • A Bachelor’s degree is required.
  • 3+ years of Systems Engineering experience.
  • Industry experience must be from a regulated environment such as Medical Device, Aerospace, Military, Space or Automotive.
  • Product development experience is highly desirable.
  • Involvement with regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and/or ISO 13485.
  • Experience with system risk/hazard analysis.
  • Experience with FDA 510(k) product/testing requirements is a plus.
  • Experience working in Quality or Regulatory capacities in the medical device industry is ideal.
  • Skilled in developing test plans and validation protocols in a regulated environment.
  • Capability of using automated software testing tools.
  • Familiarity with numerical analysis and methods.
  • Demonstrable experience in performing risk assessment, software validation and testing.


Additional Information

All your information will be kept confidential according to EEO guidelines.



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