Systems Engineer at Jobisite / employment-usa.net

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Systems Engineer

at Jobisite in Ohio

SYSTEMS ENGINEER

Ohio (Hybrid)

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.

Requirements

 A BachelorÂ’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.

Reference : Systems Engineer jobs

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