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Principal Verification and Validation Engineer

Company: RxSight, Inc.
Location: Aliso Viejo
Posted on: June 19, 2022

Job Description:

RxSight has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. This intraocular lens can be adjusted non-invasively while in the eye, allowing the post-cataract surgery patient to see clearly at distance without the use of eyeglasses or contact lenses. The application of light to the implanted Light Adjustable Lens (LAL---) will fine-tune the patient's lens power to their specific visual need.This technology sets the stage for a series of lens products from RxSight that will have widespread application in cataract and refractive surgery as well as outside the field of medicine. OVERVIEW:The Sr. Verification & Validation Engineer is responsible for contributing to the design, development, testing, launch, and on-market support of the medical device software for RxSight products which comprised of the Light Adjustable Lens (an intraocular lens) and the Light Delivery Device (complex opto-electro-mechanical system with embedded software). The engineer assumes the role of the subject matter expert for Verification and Validation, authors Operating Procedures and is responsible for all software testing activities for the Light Delivery Device (LDD), software tools, and COTS software. Also, the engineer will mentor other junior test engineers and collaborate with other teams and departments as necessary to fulfill the testing needs of the company.ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manage the planning and execution of testing activities
  • Develop processes and procedures that is compliant with necessary standards and regulations.
  • Provide expertise and guidance for and keep up to date with industry standards and regulations
  • Support all necessary development, extensions, and modifications of the code base throughout the software development lifecycle. This includes, but is not limited to:o Software testingo Automated test scripts developmento Documentation (e.g. requirements, design, and technical descriptions)o Issue investigationo Data analysis
    • Provide technical leadership to teams - takes a leadership role in architecture, design, development & release as they pertain to software designs and automated tests.
    • Provide mentorship and technical guidance to the team members.Required Knowledge, Skills and Abilities:
      • Expertise in embedded, real-time applications
      • Hardware and software interfacing --- Expert knowledge of software development lifecycle and configuration management, design controls, risk management, verification and validation
        • A strong understanding of medical device standards, including ISO 13485, ISO 14971, IEC 62304, and IEC 62366
        • Capable of software design and coding with a focus on testability, robustness, and performance, or a demonstration of the ability to quickly learn any missing elements.
        • Cybersecurity experience is highly preferred.EDUCATION, EXPERIENCE, and TRAINING:
          • Bachelors or Masters degree in a technical field and more than 5 years related experience and/or training; or equivalent combination of education and experience.
          • Training to be completed per the training plan for this position as maintained in the document control system.COMPUTER SKILLS: Preferred
            • C/C++/C#/Python/QT (qml/qt quick)/SQL/MongoDB/Json/XML/Squish
            • Windows
            • MATLAB
            • Test Management Tool (Helix ALM, Jira, Microsoft TFS, etc)
            • Project Management System
            • Defect Management System (Helix ALM, Bugzilla, etc
            • Source Control (Subversion, GitHub, etc)

Keywords: RxSight, Inc., Aliso Viejo , Principal Verification and Validation Engineer, Engineering , Aliso Viejo, California

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