Nonin Medical, Inc.

  • Sr. Systems Engineer

    Job Locations US-MN-Plymouth
    ID
    2018-1235
    # of Openings
    1
    Category
    Research & Development
    Type
    Regular Full-Time
  • Overview

    The Sr. Systems Engineer will use a systems approach to provide definition to product development projects, identify and specify critical interfaces, and ensure end products are suitable to meet the needs of their users. Through direct interaction with customers, users, internal and external stakeholders, and subject matter experts, the Sr. Systems Engineer will define stakeholder requirements and ensure the requirements are met through the product development process. Depending on the level of complexity of a project, they may lead or participate in systems-level design activities, as well as having primary responsibility for user-focused risk analyses and mitigation plans.

     

    Essential Job Functions:

    • Using a systems approach, lead cross-functional efforts to capture holistic definitions of medical device systems and interfaces.
    • Work directly with customers and end-users to understand their needs, use-cases, operating environment and processes. Communicate the information with colleagues throughout the business.
    • Work with customers and end-users to provide continuous validation throughout the systems lifecycle.
    • Define, document, review, and communicate system-level requirements based on stakeholder needs analysis, ensuring the design of the device meets the needs of its users throughout its life cycle.
    • Work with design engineers to translate system requirements and system risk analyses into component-level requirements, designs and risk management approaches.
    • Lead system-level risk analysis activities.
    • Lead the development of communication protocol architectures and high level system interface specifications, including electrical, mechanical, and/or software interfaces.
    • Develop plans for system-level verification and validation activities.
    • Mentor other engineers and technicians.
    • Actively participate on, and at times leads, cross-functional teams to develop new devices as well as address design issues or maintenance of existing products. Responsible for design/development activities which may include leading, participating, or supporting:
      • Stakeholder Interviews
      • Concept, planning, design and execution stages
      • Requirements Management
      • Risk assessment
      • Prototyping/testing
      • Pilot Production
      • Design reviews
      • Manual creation
      • Verification & Validation
      • Pre-production
      • Post-Release Monitoring & Maintenance
    • Responsible for recording and sharing technical knowledge gained with colleagues.
    • Lead and/or participate in efforts to continuously improve the operation of the Systems Engineering team.

    Minimum Qualifications:

    Required Education & Experience:

    • Bachelor’s Degree in relevant engineering discipline (e.g. Electrical, Mechanical, Software, Biomedical, or Systems); or equivalent combination of education and experience.
    • 7+ years of relevant engineering experience, including product definition and systems design.
    • Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
    • Experience working with directly with customers to identify problems/needs and translate them into requirements.
    • Experience developing, documenting and managing product requirements for medical devices.
    • Experience leading and participating in risk analysis and mitigation activities.

    Required Knowledge, Skills & Abilities:

    • Strong computer skills (MS Word; Excel, PowerPoint, Outlook, Internet).
    • Excellent verbal and written communication skills.
    • Excellent problem-solving skills.
    • Strong attention to detail.
    • Customer-focused, results-driven, “can-do” attitude.

    Preferred Qualifications:

    • Experience leading cross-functional projects.
    • Experience interacting with medical device users and exposure to clinical usage of medical devices.
    • Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
    • Systems Engineering degree or certification.
    • Experience with Requirements Management tools (eg. Polarion, Jama, Doors).
    • Experience with user interface definition, design and development.

    Physical Requirements:

    • Sit/stand/walk for 8 hours per day.
    • Ability to travel up to 15% of the time.

     

    Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.

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