ABOUT THORNHILL MEDICAL:
Thornhill Medical’s ground-breaking products are designed to be used globally by emergency health care providers, humanitarian, and military medical teams. Thornhill’s oxygen-focused research and applications are transforming patient care in extreme circumstances, while inspiring and enabling other new technologies to unlock vital life-saving solutions. Thornhill Medical’s innovations are in 19+ countries including Ukraine. With a team committed to courage, collaboration and saving lives, Thornhill Medical leads the way in the nimble and precision-focused field of medical technologies.
POSITION SUMMARY:
The Software V&V Test Engineering Specialist - fMRI/ Neuroimaging is responsible for the verification and validation of advanced neuroimaging SaMD software, including statistical BOLD fMRI analysis pipelines. This role designs and executes rigorous test strategies—including synthetic data generation—to ensure accuracy, safety, and regulatory compliance across the software lifecycle. The position bridges algorithm validation, clinical use-case verification, and regulatory documentation.
DUTIES & RESPONSIBILITIES:
Test Planning and Strategy:
- Develops comprehensive test plans based on product requirement and specifications for complex MR imaging analysis software.
- Defines and executes test strategies for integration testing, system testing, and acceptance testing by working closely with the design and development and clinical operation teams.
Algorithm Validation, Synthetic Data Generation & Test Design:
- Designs and generates synthetic and simulated BOLD fMRI datasets to validate algorithm accuracy under controlled physiological and noise conditions.
- Develops ground-truth models for signal validation (hemodynamic response, noise models, artifacts, etc.).
- Develops and maintains automated test scripts for repetitive and critical test scenarios and incorporate into CI/CD pipeline
- Creates and executes verification and validation procedures to ensure that products meet requirements.
- Executes tests to validate system functionality, performance, and reliability.
- Conducts regression testing to ensure the stability of existing features after modifications.
- Maintains and verifies traceability between software requirements, test cases, test results, and identified defects.
Defect Tracking and Reporting:
- Identifies, documents, and tracks defects arising during testing using a systematic approach.
- Generates and communicates detailed defect summaries, and overall product quality status.
Collaboration:
- Works closely with development and clinical teams to understand product architecture and design.
- Participates in the assessment of potential hazards and devises appropriate tests to verify mitigation of identified risks.
- Supports the development of DHF documents (DFMEA, SYRS, HAZ, V&V, etc.).
Documentation:
- Ensures that testing processes and documentation comply with relevant industry standards and regulations (e.g., ISO 13485, IEC 82304).
Other:
- Considers quality in all aspects of the job and respects procedures and norms.
- Other duties as assigned.
EDUCATION & EXPERIENCE:
- Bachelor’s degree in software engineering or related field.
- Master’s degree preferred with specialization in mathematics, MR physics or related analytical field.
- 5+ years of related experience working with MR analysis and/or fMRI software.
- Experience with mathematical modeling of brain imaging.
- Experience with SaMD product development lifecycle.
SKILLS & KNOWLEDGE:
- Strong in statistical modeling and signal processing/time series analysis, including brain segmentation algorithms.
- Knowledge of DICOM standard in medical imaging.
- Knowledge of BOLD fMRI processing methodologies and analytical techniques for verifying implementations
- Proficiency in python and/or MATLAB for test development and simulation.
- Experienced with operations of AFNI or similar fMRI analysis packages
- Familiar with IEC 82304, ISO 13485 Quality System and ISO 14971 standards.
- Familiar with Medical Device Regulations (Health Canada, FDA and EMA).
- Strong organizational awareness with excellent analytical skills.
- Methodical approach to work with strong attention to detail.
- Excellent verbal and written communication skills.
- Strong interpersonal skills with ability to work independently.
- Ability to build strong relationships and work collaboratively with cross-functional teams to meet shared objectives.
- Drive to consistently achieve results, even under tough circumstances.
- Holds self and others accountable to meet commitments.
- Strong computer skills and proficiency with Microsoft Office suite products (Word, Excel, PowerPoint).
OTHER REQUIREMENTS:
- Primarily office environment with exposure to in-house testing laboratories and production work rooms when required.
- Lifting (up to 50 lbs) and bending.
- Some travel may be required.
COMPENSATION:
The target salary range for this position is $75,000 – $95,000 per annum.The position is not eligible for bonus or benefits.
The starting salary offered to a candidate will be dependent upon several factors, including but not limited to experience, job-related skills and relevant education and/or training.
This job posting is to fill a new temporary position within our organization. The recruitment process involves the use of artificial intelligence.
Thornhill Medical welcomes and encourages applications from all qualified people, including those with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
We thank all applicants for their interest, however, only those selected will be invited for an interview.
Job Types: Full-time, Permanent
Pay: $75,000.00-$95,000.00 per year
Benefits:
- On-site gym
- On-site parking
Application question(s):
- How many years of experience do you have working with MR analysis and/or fMRI software?
- Are you okay with working in a hybrid environment?
Education:
- Bachelor's Degree (required)
Work Location: Hybrid remote in North York, ON M6B 1P5
