About the role

Clinical Systems Developer investigating failures in Profound Medical’s MRI-guided tissue-ablation devices. Driving root-cause analysis, safety mitigations, and corrective actions across complex subsystems.

Responsibilities

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

Bachelor’s degree in Systems, Electrical, Mechanical, Biomedical, Software, or a related engineering discipline
5 or more years of engineering experience with complex electromechanical or electronic systems, including hands-on troubleshooting and root cause analysis
Demonstrated ability to investigate failures across hardware and software/firmware domains
Proficiency with fault tree analysis, FMEA, 5 Whys, and DOE
Strong data-analysis skills using Python, MATLAB, or similar
Comfort with oscilloscopes, multimeters, and data acquisition equipment
Ability to read schematics, mechanical drawings, and specifications
Excellent technical writing and communication
Investigative rigor and systems thinking
Patient-safety mindset and ownership of investigations through verified corrective action
Experience in a regulated medical-device environment, including FDA 21 CFR 820, ISO 13485, and ISO 14971 risk management, desired
Familiarity with complaint handling, MDR/vigilance reporting, and CAPA processes, desired

Group RRSP
Medical benefits paid by the employer
Benefits programs eligibility
Accommodation(s) available during recruitment, selection, and/or assessment for candidates with disabilities