Profound Medical Inc.

Systems Engineer

• Lead cross-disciplinary investigations of device failures across electrical, mechanical, software/firmware, MRI, and ultrasound subsystems
• Reproduce and characterize failures in the laboratory by designing test setups, fixtures, and scripts
• Perform root cause analysis using 5 Whys, fishbone/Ishikawa, fault tree analysis, and FMEA linkage
• Develop and assess short-term workarounds and interim mitigations that keep field systems safely operational
• Communicate actionable workaround guidance to Field Service, clinical and customer sites, and internal stakeholders
• Prioritize and triage field issues based on urgency, patient safety, and business impact
• Analyze system logs, event records, sensor and telemetry data, and service records
• Examine returned and complaint units and coordinate teardown, inspection, and component or supplier analysis
• Author investigation reports meeting regulatory and quality-system standards
• Support complaint handling and MDR/adverse-event evaluation for Quality and Regulatory
• Drive and verify CAPA with design, manufacturing, and supplier teams
• Confirm corrective-action effectiveness and retire interim workarounds after permanent fixes
• Feed lessons learned into design and risk management, including Hazard Analysis, dFMEA, and pFMEA updates
• Collaborate with R&D, Manufacturing, Field Service, Regulatory, suppliers, and multidisciplinary engineering teams
• Occasionally support field or customer-site investigations

Clinical Systems Developer