Software Tester & Validation Specialist

Position Summary

Cellview Imaging is seeking a Software Tester & Validation Specialist to lead and execute verification and validation activities for our ultra-widefield retinal imaging systems (device software imaging workflows and related applications). This role is responsible for building and running structured test programs that ensure our software is safe effective compliant and release-ready-including risk-based testing requirements traceability documentation and formal software validation evidence aligned to our Quality Management System (QMS).

You will work closely with Software Engineering Systems/Hardware Clinical/Applications and Quality/Regulatory to ensure software changes are properly tested verified validated and documented to support regulatory expectations and real-world customer reliability.

Key Responsibilities

1) Test Planning & Execution (Verification)

• Own and execute the software test strategy across releases patches hotfixes and major feature updates.
• Create and maintain:
  • Test Plans / Test Protocols
  • Test Cases (functional regression integration end-to-end workflow)
  • Test Reports / Test Summaries
• Perform manual testing and support automation where practical (UI API system regression).
• Build and continuously improve a regression suite to protect core imaging workflows and device stability.
• Validate software behavior across supported configurations (OS versions device builds camera/sensor variants peripherals MiniPC/compute variants etc. as applicable).
• Ensure testing covers expected clinical workflows: patient entry acquisition review export connectivity error handling rework flows and recovery states.

2) Software Validation (Medical Device Compliance)

• Execute validation activities aligned to internal QMS and regulatory expectations (risk-based).
• Ensure validation evidence supports software releases including:
  • Validation Plan / Validation Protocol(s)
  • Objective evidence of execution (screenshots/logs controlled environment records)
  • Validation Report / Summary including deviations and resolution
• Support CSV-style thinking for software that impacts patient data and clinical workflow (as applicable).
• Ensure software updates are supported by appropriate validation especially those impacting:
  • Imaging quality and processing
  • Acquisition workflow and user interface
  • Data integrity and patient information handling
  • DICOM or external connectivity (if applicable)

3) Requirements Traceability & Documentation

• Create and maintain traceability between:
  • User needs / intended use statements
  • Software/system requirements
  • Risk controls / mitigations
  • Verification & validation test cases
  • Defects / CAPA links (as required)
• Ensure test artifacts are audit-ready: versioned reviewed approved and stored per document control requirements.
• Contribute to release documentation readiness: known issues limitations and testing coverage summaries.

4) Defect Management & Root Cause Support

• Log triage and track defects with high-quality reproduction steps logs environment context and severity rationale.
• Partner with developers to isolate issues using log files event traces and configuration replication.
• Support verification of fixes (re-test) regression risk evaluation and release go/no-go readiness.
• Identify systemic issues and propose process improvements (e.g. improved logging testability test hooks acceptance criteria).

5) Cross-Functional Collaboration & Continuous Improvement

• Participate in sprint ceremonies and release planning (as applicable): backlog grooming planning demos retros.
• Collaborate with Hardware/Optics teams to validate software behavior with physical device performance and constraints.
• Support customer-facing investigations by reproducing field issues in a controlled test environment and validating fixes.
• Drive improvements to:
  • Test coverage and efficiency
  • Documentation quality
  • Risk-based testing approach
  • Automation pipeline where feasible

Required Qualifications

• 1 years in software testing / QA with at least some experience in regulated or high-reliability environments (medical devices strongly preferred).
• Demonstrated experience writing:
  • Test plans test cases test reports
  • Validation protocols and summaries (or similar controlled documentation)
• Strong understanding of:
  • SDLC and basic agile practices
  • Defect management workflows and severity/prioritization
  • Risk-based testing principles
• Comfortable working hands-on with hardware/software systems (installations configuration device connectivity).
• Excellent communication skills-able to translate technical findings into clear actionable outcomes.

Preferred Qualifications

• Experience with medical device standards and guidance (e.g. IEC 62304 ISO 13485 environment software validation concepts).
• Experience testing:
  • Imaging systems image processing pipelines or camera/sensor-driven software
  • DICOM HL7 PACS integration or medical IT connectivity
• Automation experience with one or more:
  • Python JavaScript/TypeScript C#
  • UI automation tools (Playwright/Selenium/Cypress) API testing (Postman/Newman) CI pipelines
• Familiarity with requirements/tools like Jira Azure DevOps TestRail Zephyr Confluence Git-based workflows.
• Experience with cybersecurity or data integrity testing concepts (access control audit logs data handling).

Core Competencies

• Detail orientation with a trust but verify mindset
• Documentation discipline (controlled documents versioning evidence)
• Strong judgment on risk and release readiness
• Systems thinking across software hardware clinical workflow
• Ownership-able to run testing independently while collaborating effectively