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…