This is an opportunity to be part of a small but growing company in Vancouver, BC. You will be supporting the development, verification, validation, and lifecycle management of the company's regulated medical-device software and AI/ML-enabled products. This is a full-time hybrid role.
Reporting to the Director, Quality Systems & Validation, this position will serve as a hands-on Quality and software-validation resource working closely with Software Engineering, Product, Clinical and Regulatory Affairs.
The successful candidate will help ensure that Light AI's Software as a Medical Device (SaMD), AI/ML algorithms, mobile and cloud software, imaging interfaces and future integrated medical-device systems are developed, tested, documented and maintained in accordance with applicable medical-device quality and regulatory requirements.
This role is particularly suited to an experienced software quality analyst, software validation specialist or QA professional who understands that medical-device software testing requires documented requirements, risk-based testing, objective evidence and end-to-end traceability - not simply confirmation that the software functions.
Main Responsibilities
Software Quality & Validation
- Support development and execution of software verification and validation plans, protocols, test cases and reports.
- Review software requirements and acceptance criteria for completeness, clarity and testability.
- Develop and maintain traceability between user needs, software/system requirements, risks, design outputs and verification/validation evidence.
- Perform and document risk-based software testing.
- Review software releases to ensure required verification, validation and Quality documentation are complete before release.
- Support validation of mobile applications, cloud services, APIs, imaging interfaces, and other software components within the Light AI platform.
- Support system-level validation where software interfaces with imaging devices or other medical-device hardware.
- Ensure that test results, deviations, anomalies, and defects are appropriately documented and resolved.
SaMD & Medical-Device Software
- Support software lifecycle activities in accordance with applicable requirements and standards, including:
- IEC 62304 software lifecycle processes
- ISO 13485 quality-system requirements
- ISO 14971 risk management
- FDA Quality Management System Regulation (QMSR)
- Health Canada medical-device requirements
- FDA software documentation expectations
- Applicable cybersecurity requirements
- Software configuration and change management
- Assist in maintaining software development and design-control documentation suitable for Health Canada, FDA and other regulatory submissions.
AI/ML & Imaging Software
- Support verification and validation activities associated with Light AI's AI/ML-enabled medical-device platform, including:
- Image acquisition and image-quality requirements
- Image processing and segmentation
- Algorithm inputs and outputs
- Model performance testing
- Dataset and test-data controls
- Algorithm and model version control
- Software/model change assessment
- Performance acceptance criteria
- Regression testing following software or algorithm changes
- Hardware/software and imaging-system compatibility
- Work with Engineering, Clinical and Quality teams to ensure that technical and algorithm performance evidence is appropriately documented and traceable to product requirements and intended use.
Design Controls & Requirements Management
- Support creation, review and maintenance of user needs, system requirements, software requirements, and product specifications.
- Participate in design reviews.
- Maintain requirements for traceability matrices.
- Ensure risk-control requirements have corresponding verification evidence.
- Support Design History File and technical documentation maintenance.
- Assist with change-control assessments for software and product modifications.
- Ensure software changes are evaluated for potential impact on previously completed verification, validation, and regulatory evidence.
Software Testing & Defect Management
- Develop and execute functional, integration, system and regression test cases.
- Document test results and maintain objective evidence.
- Identify, document and track software defects and anomalies through resolution.
- Support root-cause investigations for software-related non-conformances and CAPAs.
- Work directly with developers to reproduce and characterize software issues.
- Verify corrective actions and software fixes.
- Support release-readiness reviews and ensure unresolved anomalies are appropriately assessed and documented.
QMS Support
Support the Director, Quality Systems & Validation with:
- Document control
- CAPA investigations
- Nonconformance management
- Change control
- Internal audits
- Supplier-quality activities
- Training documentation
- Software-related SOPs and work instructions
- Regulatory and certification audits
- Quality metrics and reporting
- Participate in continuous improvement of Light AI's QMS as the organization transitions from development into commercialization.
Qualifications
- Bachelor's degree in computer science, software engineering, biomedical engineering, information technology, life sciences or a related field, or equivalent relevant experience.
- Approximately 3–7+ years of software quality, software testing, validation or quality assurance experience, including experience in a regulated medical-device environment.
- Experience with Software as a Medical Device (SaMD) or software-containing medical devices.
- Practical understanding of medical-device design controls and software verification and validation.
- Experience creating and executing software test cases, protocols and validation documentation.
- Experience with requirements management and requirements-to-test traceability.
- Understanding of software defect and anomaly management.
- Familiarity with ISO 13485 and IEC 62304.
- Ability to work effectively with software engineers while maintaining Quality independence and appropriate documentation standards.
- Strong technical writing and documentation skills.
Ideal candidate will have experience the following:
- FDA-regulated medical-device software
- Health Canada-regulated medical devices
- FDA 510(k), De Novo or other medical-device submissions
- Working within an ISO 13485/MDSAP-certified organization
- AI/ML-enabled medical devices
- Medical imaging or image-analysis software
- Testing mobile applications and cloud-connected medical-device software
- Jira or similar issue-tracking systems and software-development tools
- Familiarity with software cybersecurity requirements for medical devices
- Automated software testing
The ideal candidate combines the mindset of a software analyst/tester with the discipline of medical-device Quality.
This individual should be comfortable working directly with software engineers, reviewing requirements, testing software builds, investigating defects and documenting objective evidence while understanding why each activity matters within an ISO 13485 and FDA-regulated design-control environment.
The successful candidate will be detail-oriented and technically capable but also pragmatic. Light AI needs someone who can identify gaps, document them appropriately and work collaboratively with Engineering to resolve them rather than operating solely as a compliance reviewer.
Experience with AI/ML or medical imaging is highly desirable, but strong SaMD and medicaldevice software validation experience is more important.
Initial Priorities
During the first 90 days, the Software Quality Analyst will:
- Become familiar with the QuickScan™ software architecture, development lifecycle and existing software documentation.
- Review existing software requirements, test cases, verification evidence, defects and release documentation.
- Support the Director, Quality Systems & Validation in completing a software validation gap assessment.
- Strengthen traceability between product requirements, software requirements, risks and test evidence.
- Establish or improve standardized software verification and validation documentation.
- Support regression and system testing of current and upcoming QuickScan™ software releases.
- Review software anomaly and defect-management processes.
- Support development of a repeatable, compliant software release-readiness process.
- Assist in identifying software-validation evidence required for future FDA submissions.
- Support integration of software Quality activities into Light AI's broader product validation strategy.
Compensation
The total compensation for this role will be dependent on the individual experience and skillset of the candidate. The upper half of the salary range is typically reserved for individuals who have demonstrated consistent strong performance in the role and possess a high level of job knowledge and skill.
Equal Opportunity Employment
Light AI is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including gender identity), national origin, political affiliation, parental status, marital status, sexual orientation, disability, age, or other non-merit factors. Accommodation is available to all applicants upon request throughout our recruitment and selection process. We will work with all applicants to accommodate their accessibility needs.
