Preferred location is in Winnipeg, Canada

Company Description

Monteris Medical is the creator of the NeuroBlate® System, an advanced minimally invasive, robotic laser interstitial thermal therapy (LITT) designed for MR-guided brain surgeries. This innovative technology is utilized for precise ablation of brain lesions, including tumors, radiation necrosis, and epileptogenic foci in patients with drug-resistant epilepsy. Backed by strong clinical evidence, the NeuroBlate® System has been shown to support shorter hospital stays, reduced complications, and lower readmission rates. Monteris Medical is dedicated to improving patient outcomes through cutting-edge neurosurgical solutions.

Role Description

Purpose and Scope

The responsibilities of this role are focused on leading and managing the software engineering, software verification and validation (V&V) deliverables within Monteris Medical. The Manager, Software Engineering and V&V will be responsible for leading software test and automation teams and overseeing all verification and validation testing activities associated with software and integrated system releases. This role is responsible for establishing scalable automated testing frameworks, ensuring synchronization between requirements managed in Jama and automated test execution pipelines in Jenkins, and driving continuous improvements in testing efficiency and product quality. The incumbent must possess a systems-level perspective and deep technical understanding of highly regulated software systems.

Primary Organization Responsibilities

• Lead, mentor, and manage software verification analysts and test automation engineers.

• Support software team in establishing robust development, integration, and testing practices.

• Provide technical leadership and coaching to team members to support professional growth and engineering excellence.

• Develop and maintain the Design Verification and Validation Master Plan (DVMP) and Design Verification and Validation Master Report (DVMR) for medical device software projects.

• Own and lead all software and system testing activities associated with product releases, including planning, execution, defect management, reporting, and closure.

• Develop, implement, and continuously improve automated testing frameworks and infrastructure to improve test efficiency, reliability, and coverage.

• Review and approve software test strategies, test protocols, test cases, and test reports for all projects.

• Ensure traceability and synchronization between Jama requirements, risk controls, and automated test cases executed through Jenkins pipelines.

• Collaborate with software, systems, hardware, quality, regulatory, and clinical teams to ensure end-toend verification and validation coverage.

• Participate in software requirements analysis and design reviews to ensure testability, traceability, and compliance with design control requirements.

• Drive continuous integration and continuous testing initiatives in alignment with Agile and DevOps methodologies.

• Support compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, CSA, and Health Canada.

• Provide leadership for defect triage, root cause analysis, risk assessment, and corrective actions related to software quality.

• Establish testing metrics, dashboards, and reporting mechanisms to communicate project quality and testing status.

• Support audits, inspections, and regulatory submissions by ensuring all verification and validation documentation is complete and audit ready.

• Review and maintain verification environments, automated test tools, and laboratory equipment required for software/system validation activities.

• Work closely with project managers and engineering leadership to prioritize activities, mitigate risks, and ensure on-time project delivery.

• Participate in risk management activities and ensure risk mitigations are appropriately verified and validated.

• Perform other duties as assigned.

Personal Qualifications and Experience

Education/Experience

• Bachelor’s degree required in software engineering, computer science, systems engineering, or related technical field.

• Minimum of eight (8) years of experience in software verification and validation within a regulated environment.

• Minimum of three (3) years leading or managing software testing or engineering teams.

• Demonstrated experience developing automated testing frameworks and CI/CD-based validation pipelines.

• Strong working experience with C#, WPF, and C++ software development and testing.

• Experience developing and maintaining DVMPs, DVMRs, traceability matrices, and formal verification and validation documentation.

• Experience with requirements management and traceability tools such as Jama.

• Experience with automation orchestration tools such as Jenkins.

• Experience with DICOM standards and Python scripting is considered an asset.

Skills/Abilities

• Strong leadership and people management capabilities with the ability to mentor and develop technical teams.

• Strong systems engineering mindset with the ability to understand complex integrated hardware/software systems.

• Excellent verbal, written, presentation, and interpersonal communication skills.

• Strong organizational and project coordination skills with attention to detail.

• Demonstrated ability to lead verification and validation efforts across multiple concurrent projects.

• Strong analytical, troubleshooting, and root-cause investigation skills.

• Strong understanding of software development lifecycle (SDLC), verification methodologies, and software quality assurance principles.

• Knowledge of automated testing methodologies, software quality assurance principles, and validation best practices.

• Ability to work effectively in a fast-paced, regulated development environment.

• Knowledge of Agile development methodologies and DevOps/continuous integration practices.

• Ability to communicate effectively with internal stakeholders, external vendors, auditors, and regulatory agencies.