Senior Software Verification & Validation Engineer

RxSight, Inc. • Aliso Viejo, CA

2d • $100,000 - $130,000

About The Position

The Senior Software 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, co-authors Operating Procedures and is responsible for software testing activities for the Light Delivery Device (LDD), software tools, and COTS software. Also, the engineer will collaborate with other teams and departments as necessary to fulfill the testing needs of the company.

Requirements

• Expertise in embedded, real-time applications
• Hardware and software interfacing
• Proficient in software development lifecycle and configuration management, design controls, risk management, verification and validation
• A working knowledge 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.
• Leading and managing projects and deliverables
• Ability to work independently and collaboratively in a fast-paced environment
• 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.
• 5+ years of project leadership

Nice To Haves

• 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)

Responsibilities

• Lead the planning and lead the execution of testing activities
• Develop processes and procedures that are compliant with necessary standards and regulations.
• Act as key interface with regulatory bodies and contribute to regulatory submissions and audits
• Support all necessary development, extensions, and modifications of the code base throughout the software development lifecycle. This includes, but is not limited to: Software testing, Automated test scripts development, Documentation (e.g. requirements, design, and technical descriptions), Issue investigation, Data analysis
• Develop expertise in and keep up to date with industry standards and regulations
• Provide technical guidance to the team members.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior