- 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 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.
- 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
- 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.
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Systems Engineer - Cleveland, United States - Research Group Inc
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