Job Title: Manager Software Engineering and V&V
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.