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Minnesota - Twin Cities

  • Systems Engineer

    SUMMARY:

    Based out of our headquarters in Brooklyn Park, MN, the Sr. Systems Engineer will be mainly responsible for system-level development and implementation of electronic and software designs for novel Class II and III medical devices.

    Responsibilities:
    • Lead system architecture design, sub-system requirements partitioning, requirements management and configuration management during product development.
    • Develop system requirements, technical specifications and development plans based on marketing and regulatory needs, and applicable standards.
    • Ensure that all hardware and software requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability and serviceability within the constraints of the project schedule and budget.
    • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams.
    • Manage and lead resolution of systems engineering issues including systems architecture, hardware and software design trade-offs.
    • Develop verification and test plans and protocols, and manage prototype testing and design verification testing.
    • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development.
    • Lead and contribute in creation of risk management documentation, including Failure Mode Effects Analysis.
    • Develop and maintain documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files.
    • Manage and assist in creation of manufacturing process instructions, bills of material, quality inspection, and related documentation.
    Requirements:
    • BS in Electronics or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
    • Experience with development of neuro-modulation devices highly preferred.
    • Demonstrated expertise in systems engineering and requirements management.
    • Working knowledge of medical device regulatory standards, for e.g. IEC 60601 and related standards.
    • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.

     

     


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