Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.
If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.
General Accountability
We are seeking a Clinical Systems Engineer to lead the technical investigation of device failures across the product lifecycle — reproducing failures, tracing them to root cause across hardware, software, firmware, and mechanical subsystems, developing and communicating short-term workarounds to keep systems safely operational, and driving the corrective actions that improve device safety and reliability.
Duties & Responsibilities
Duties and responsibilities will include (but are not limited to):
- Lead cross-disciplinary investigations of device failures on complex, multi-subsystem medical devices, spanning electrical, mechanical, software/firmware, and MRI/ultrasound components.
- Reproduce and characterize failures in the lab, including designing test setups, fixtures, and scripts to recreate field-reported conditions.
- Perform root cause analysis using structured methods (5 Whys, fishbone/Ishikawa, fault tree analysis, and FMEA linkage) and document findings with clear evidence and reasoning.
- Develop short-term workarounds and interim mitigations to keep systems safely operational in the field while permanent root cause fixes are investigated and implemented.
- Assess the safety and risk of proposed workarounds, ensuring interim measures do not introduce new hazards and are consistent with the device’s risk management file.
- Clearly communicate workarounds and interim guidance to Field Service, clinical and customer sites, and internal stakeholders, providing concise, actionable instructions along with the rationale and limitations behind them.
- Prioritize and triage field issues, balancing urgency, patient safety, and business impact to determine when an immediate workaround is warranted versus a full corrective action.
- Analyze device data — system logs, event records, sensor and telemetry data, and service records — to isolate failure signatures and distinguish root causes from symptoms.
- Examine returned and complaint units, coordinating teardown, inspection, and any needed component-level or supplier analysis.
- Author investigation reports that meet regulatory and quality-system standards, clearly stating scope, evidence, root cause, and recommended corrective and preventive actions.
- Support complaint handling and MDR / adverse-event evaluation, providing timely, technically sound conclusions to Quality and Regulatory.
- Drive and verify corrective actions (CAPA) with design, manufacturing, and supplier teams; confirm effectiveness of implemented fixes and ensure interim workarounds are retired once permanent solutions are in place.
- Feed lessons learned back into design and risk management, updating risk files (Hazard Analysis, dFMEA/pFMEA) and informing design improvements.
- Work with suppliers and multidisciplinary engineering teams (R&D, Manufacturing, Field Service, and Regulatory), and occasionally support field or customer-site investigations.
Education & Certifications
Bachelor’s degree in Systems, Electrical, Mechanical, Biomedical, Software, or a related engineering discipline
Key Attributes
Required:
- 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 multiple domains (hardware and software/firmware) and to reason rigorously from evidence to conclusion.
- Proficiency with structured root cause methodologies (fault tree analysis, FMEA, 5 Whys, DOE).
- Strong data-analysis skills: interpreting logs, sensor data, and test results (e.g., Python, MATLAB, or similar).
- Comfort with laboratory instrumentation (oscilloscopes, multimeters, data acquisition) and reading schematics, mechanical drawings, and specifications.
- Excellent technical writing and communication — able to make complex findings clear and defensible, including under time pressure.
- Investigative rigor and systems thinking — methodical, evidence-driven, and able to see interactions across subsystems rather than isolated components.
- Patient-safety mindset with strong ownership, driving investigations from complaint through to verified corrective action.
Desired:
- Experience in a regulated medical-device environment (FDA 21 CFR 820, ISO 13485, ISO 14971 risk management).
- Familiarity with complaint handling, MDR / vigilance reporting, and CAPA processes.
We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.
The expected annual salary range for this role is $75,000 -$120,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.
We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.
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