Senior Embedded Software V&V Engineer — Medical Devices

RxSight, Inc.

Aliso Viejo (CA)

On-site

USD 120,000 - 170,000

Full time

4 days ago
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Job summary

RxSight, Inc. in Aliso Viejo, CA, seeks a Senior Software Verification & Validation Engineer to lead testing activities for medical device software used in the Light Adjustable Lens system. You’ll contribute to design, development, testing, launch, and on-market support.

The role requires deep embedded real-time expertise, regulatory acumen, and the ability to collaborate across teams while guiding the development lifecycle and validating software against ISO standards.

Qualifications

  • Expertise in embedded, real-time applications
  • Hardware and software interfacing
  • Proficient in software lifecycle, configuration management, design controls, risk management, verification and validation
  • Working knowledge of medical device standards ISO 13485, ISO 14971, IEC 62304, IEC 62366
  • Capable of software design and coding with a focus on testability, robustness, and performance
  • Cybersecurity experience is highly preferred
  • Leading and managing projects
  • Ability to work independently and collaboratively in a fast-paced environment

Responsibilities

  • Lead the planning and execution of testing activities
  • Develop processes and procedures compliant with necessary standards and regulations
  • Act as interface with regulatory bodies and contribute to regulatory submissions and audits
  • Support development, extensions, and modifications across the software lifecycle: testing, automated tests, documentation, issue investigation
  • Develop expertise in industry standards and regulations
  • Provide technical guidance to team members

Skills

Embedded real-time
Hardware interfacing
Software lifecycle
Regulatory compliance
Testable software design
Cybersecurity
Project leadership
Independent work

Education

Bachelor's or Master's in technical field
5+ years related experience
Project leadership experience

Tools

C/C++/C#/Python/QT
MATLAB
Helix ALM / Jira / TFS
Git/Subversion

Job description

RxSight, Inc. in Aliso Viejo, CA, seeks a Senior Software Verification & Validation Engineer to lead testing activities for medical device software used in the Light Adjustable Lens system. You’ll contribute to design, development, testing, launch, and on-market support.

The role requires deep embedded real-time expertise, regulatory acumen, and the ability to collaborate across teams while guiding the development lifecycle and validating software against ISO standards.

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