Job Title: Quality Technical Support Engineer

Department: Operations

Reports To: Director, Clinical Operations

Engagement Type: Contract Position

About VoxNeuro

VoxNeuro is a Toronto-based medical device software company, spun out of McMaster University and founded on the work of neuroscientist Dr. John F. Connolly. Our purpose is to move objective measurement of brain function out of the research laboratory and into routine clinical practice.

Our Cognitive Function Neuroimaging (cfNI) Software is FDA-cleared under 510(k) K253015. It is Class II, prescription-use software for qualified healthcare professionals that performs digital post-hoc statistical analysis of the human electroencephalogram (EEG), including event-related potentials (ERPs), for use in adults 18 to 70 years of age with the Resting State, Auditory Oddball, Go No-Go, Continuous Visual Memory Test and Eriksen Flanker tasks. cfNI compares a patient's EEG and ERP measures against an age-matched reference database and produces a standardized outcome report that supports interpretation by a qualified clinician. The device does not provide a diagnosis or clinical interpretation.

Summary of Position The Quality Technical Support Engineer will be responsible for independent verification and validation of the cfNI software, for the maintenance of design and development documentation and traceability, and for defect and requirement management. They will also be responsible for second-line technical support of the cfNI Software, for the technical investigation of complaints and nonconformances. The position works alongside Product Development as a peer and is embedded in the day-to-day development workflow, while reporting outside of Product Development in order to preserve the independence of verification and validation activity.

The position exists to establish and maintain verification and validation performed independently of the author of the software, within a controlled and documented test environment, and to ensure that design outputs, test evidence, defect records, and traceability are complete and audit-ready across releases. The position is also the second-line technical resource for customer-reported software issues escalated by the first-line Clinical Operations staff, and the investigator of record for complaints and nonconformances, producing the analysis on which complaint handling and reportability determination depend.

Essential Duties and Responsibilities

Software Design and Development; Verification and Validation

- Execute and document verification and validation activities independently of the individuals who authored the software under test, in accordance with applicable Quality System Procedures and IEC 62304, against the approved Software Requirements Specification and Software Design Specification, and Verification Protocol / Validation Protocol.
- Author Verification / Validation artifact sheets that record objective evidence and pass/fail determinations against approved software requirements, in accordance with defined verification and validation plans / protocols.
- Establish and maintain a controlled test setting with documented configuration, separate from the development environment, and maintain records sufficient to demonstrate the configuration under which testing was performed.
- Design,



execute, and maintain the regression test suite, and execute regression testing for each release, as applicable.
- Maintain anomaly logging, ensuring known anomalies are characterized, risk-assessed, dispositioned, and communicated.
- Participate as an independent reviewer in Design Reviews.
- Capture, document, and maintain software requirements in verifiable form, and confirm that each requirement is testable prior to acceptance.

Defect, Requirement, and Ticket Management
- Administer the issue tracking system of record (Jira), including workflow configuration, issue types, fields, and reporting, and maintain the integrity and completeness of records within it.
- Log, reproduce, characterize, classify, and assign severity to defects, including reproduction steps, environment, and observed and expected behaviour.
- Maintain the enhancement and feature request backlog in documented form, including requests originating from customer support activity and post-install feedback.
- Link defect records to affected requirements and to the risk management file so that identified defects are assessed for risk impact.
- Compile and report software quality and support metrics.

Second-Line Technical Support and Investigation
- Serve as the second-line escalation point for customer-reported cfNI software issues raised by first-line Clinical Operations staff, acknowledging and responding within the timelines defined in the relevant process.
- Diagnose reported issues through log analysis, configuration and environment comparison, and reproduction in the controlled test environment, and characterize the failure precisely before escalation.
- Investigate nonconformances, including root cause analysis and proposed correction, and execute or support effectiveness verification.
- Perform technical investigation of complaints, including root cause analysis, determination of scope of impact, and identification of affected software versions and customer installations, and document the investigation to support complaint handling and reportability determination by the Director, within the timelines defined by company procedures.
- Escalate to Product Development only those issues requiring code change, accompanied by documented reproduction and characterization.
- Maintain a record of each support interaction sufficient to support complaint determination, trend analysis, and post-market surveillance.
- Execute customer account closure at off-boarding and execute protected health information destruction requests, with documented confirmation of completion.
- Other duties as assigned

Supervisory Responsibilities

This position has no direct reports. The position works alongside the Product Development team as a peer and does not report to, and is not supervised by, Product Development.



This reporting structure is established to maintain independence of verification and validation activity from software development activity. The incumbent has no authority to direct the technical design, architecture, or implementation decisions of Product Development.

Qualifications Required for Position

Required

- Three to six years of experience in software quality assurance, software test engineering, software quality engineering, or technical support engineering with a documented test or quality component.
- Demonstrated ownership of a test process, including test planning, test case design, execution, and defect management, rather than execution of test scripts authored by others.
- Working proficiency with Jira, including issue types, fields, workflow configuration and reporting, with demonstrated discipline in maintaining the integrity, traceability and completeness of the records held within it.
- Ability to read source code sufficiently to reason about a defect, reproduce it reliably, and characterize the failure precisely. Authorship of production code is not required.
- Demonstrated technical writing capability sufficient to author test plans, defect reports, and investigation records; assessed by writing sample and written exercise during selection.
- Demonstrated experience supporting external customers directly, in writing and verbally, including non-technical clinical users, against defined response expectations.
- Post-secondary education in computer science, engineering, life sciences, or a related discipline, or equivalent practical experience.

Preferred

- Experience in medical device software, Software as a Medical Device, or another regulated software environment.
- Familiarity with IEC 62304, ISO 13485:2016, 21 CFR Part 820.30, or IEC 62366-1.
- Test automation capability, including scripting in Python or comparable languages and use of automated test frameworks.
- Familiarity with cloud infrastructure, relational databases, structured query languages, and log analysis.
- Familiarity with EEG, signal processing, or clinical data.
- Experience performing root cause analysis or complaint investigation in a regulated setting.
- Experience working escalations within a defined support tier structure, including ownership of a queue and reporting against response and resolution targets.
- ISTQB or comparable software testing certification.

Not Required
- A computer science degree, production software development experience, prior medical device experience, or certification are not required for this position.

Work Environment

Hybrid work arrangement based in Ontario, Canada, combining remote work with periodic in-person attendance in Toronto, Ontario. Standard business hours with occasional flexibility required to accommodate release schedules, scheduled testing activity, and support coverage across United States and Canadian business hours.

The position is primarily computer-based and office- or home-office-based, involving extended periods of screen work. The position requires access to the controlled test environment, to development and issue tracking systems, and to cloud infrastructure containing protected health information, and is subject to applicable privacy, confidentiality, and information security requirements. Occasional travel may be required for customer site activities and company meetings.

📌 Quality Technical Support Engineer (Toronto)
🏢 VoxNeuro
📍 Toronto