Job Description Job Title: Manager Software Engineering and V&V Location: Winnipeg (remote) Role: Full-Time Permanent Our client is seeking a Software Engineering and V&V Manager to lead their software testing and automation engineering teams. In this role, you will drive the end-to-end testing strategy, develop automated testing frameworks, and ensure rigorous regulatory compliance for complex medical device software systems from concept to release. 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-to-end 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. Qualifications 8+ years of experience in software verification and validation within a regulated environment.
3+ years of experience 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. 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.