Principal Verification and Validation Engineer
Company: RxSight, Inc.
Location: Aliso Viejo
Posted on: June 19, 2022
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
- 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
- C/C++/C#/Python/QT (qml/qt
- 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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