Senior Software Verification & Validation Engineer

Regulatory Toolkit; Aliso Viejo (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

RxSight is seeking a Senior Software Verification & Validation Engineer in Aliso Viejo, CA to lead testing for the Light Delivery Device software and related tools. You will contribute across the software lifecycle, from requirements to on-market support, with emphasis on embedded real-time systems.

The role requires collaboration with regulatory bodies, development teams, and quality processes to ensure robust, compliant software for ophthalmic devices.

Qualifications

• Bachelor's or Masters degree in a technical field with 5+ years of related experience.
• Strong expertise in embedded, real-time applications and software testing.
• Experience with regulatory standards and quality systems in medical devices.

Responsibilities

• Lead the planning and execution of software testing activities for medical device software.
• Develop compliant processes and procedures aligned with industry standards and regulations.
• Act as interface with regulatory bodies and support regulatory submissions/audits.
• Support code development lifecycle including testing, automation scripts, and documentation.
• Provide technical guidance and mentorship to team members.

Job description

Description

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

OVERVIEW:

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.

This is a fully onsite position at our headquarters in Aliso Viejo, CA so candidates must reside in or near this city.

Requirements

ESSENTIAL DUTIES AND 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
• Act as key interface with regulatory bodies and contribute to regulatory submissions and audits
• Provide technical guidance to the team members.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• 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

SUPERVISORY RESPONSIBILITIES:

• None

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.
• 5+ years of project leadership
• Training to be completed per the training plan for this position as maintained in the document control system.

CERTIFICATES, LICENSES, REGISTRATIONS:

• N/A

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)