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Senior Systems Engineer, Risk Management.

Company: Johnson & Johnson
Location: Santa Clara
Posted on: January 16, 2022

Job Description:

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Systems Engineer, Risk Management located Santa Clara, CA.

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopaedics, endoluminal intervention and general surgery. This includes the MONARCH-- platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com

The Senior Systems Engineer will have a role in the risk management of J&J's most advanced robotic surgical system. The engineer will apply an interdisciplinary systems engineering approach to risk management, requirements management, and safety architecture. In addition, the Engineer will be expected to contribute significantly to establishing standard procedures and good engineering practices of the above activities in the team, to meet all safety and regulatory compliance. The successful candidate will be able to lead the resolution of risk problems that are by nature, highly unstructured and uncertain.

Core Job Responsibilities

  • Work with HW, SW, systems, quality, and clinical engineering teams to lead risk analysis activities at a system level, identifying proper risk mitigation solutions to the complex robotic surgical system and subsystems
  • Work across engineering teams to create, manage, and track system- and subsystem-levels of risk mitigation requirements and specifications
  • Develop new processes to identify and manage risk for a complex robotic surgical system
  • Propose and lead new safety related design input requirements
  • Ensure systems design and documentation meet all safety and regulatory compliance
  • Contribute significantly to establishing the best engineering practices in the full product development cycle for the entire team
  • Other related duties as may be assigned

    Required

    Qualifications
    • Bachelor's degree in Electrical, Mechanical, Systems Engineering or related Engineering degree is required. Advanced degree in systems engineering, robotics, mechanical engineering, mechatronics, or, other related field is preferred
    • 4+ years of related work experience or an equivalent combination of work experience & internships is required.
    • Experience within Medical Device or a regulated industry through full product development cycle of complex electromechanical systems, from initial concept to release to market is required
    • Understanding of systems, mechatronics, and software integration is required
    • Strong experience with Risk Management and ISO 14971 or equivalent federally regulated standard(s) is required
    • Demonstrated technical leadership and issue ownership; proven ability of analytical problem solving, and troubleshooting is required

      Preferred
      • Experience supporting requirement development is preferred
      • Experience with medical device robotics is preferred
      • Expertise in design and development processes that conform to standards, including IEC 60601, IEC 62304, etc., and ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 82 is highly preferred
      • Ability to travel up to 10%, international or domestic is required

        Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

        Primary Location

        United States-California-Santa Clara-5490 Great America Pkwy

        Organization

        Verb Surgical Inc. (6270)

        Job Function

        R&D

        Requisition ID

        2105930700W

Keywords: Johnson & Johnson, Santa Clara , Senior Systems Engineer, Risk Management., Executive , Santa Clara, California

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