Senior Software Verification & Validation Engineer

RXSIGHT INC; Aliso Viejo (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

RxSight, based in Aliso Viejo, CA, is seeking a Senior Software Verification & Validation Engineer to drive testing of the Light Delivery Device software and related tools. This onsite role requires deep experience with embedded, real-time software and involvement in regulatory submissions.

You will co-author procedures, lead test planning, and collaborate across teams to ensure software quality and regulatory readiness for medical device products.

Qualifications

• Expertise in embedded, real-time applications.

Responsibilities

• Lead the planning and execution of testing activities.
• Develop processes and procedures compliant with standards and regulations.
• Interface with regulatory bodies and support submissions and audits.
• Support development, extensions, and modifications of the software lifecycle including testing, automation scripts, documentation, and data analysis.

Skills

Embedded systems

Hardware interfacing

Software lifecycle

Regulatory knowledge

Cybersecurity

Project leadership

Independent/collaborative work

Education

Bachelors or Masters in technical field

Tools

C/C++

Python

QT

SQL

MongoDB

JSON/XML

Squish

Helix ALM

Job 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.

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)

Notice to Staffing Agencies and Search Firms

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight's Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.