Position: Hardware Validation Specialist

Roles and Responsibilities

• Plan, execute, and maintain hardware validation and verification activities throughout the device development and manufacturing lifecycle.
• Investigate returned devices (RMAs) to identify hardware failures, perform root cause analysis, and document findings.
• Support the Technical Service team by reproducing issues and confirming suspected hardware defects.
• Collaborate with electrical, firmware, mechanical, and software developers to debug hardware issues and define corrective actions.
• Execute Failure Mode and Recovery Testing, including fault injection, load simulation, and abnormal condition testing.
• Assist with performance testing, reliability testing, stress testing, Transportation & Packaging Testing and environmental testing (e.g., thermal, vibration, electrical stress).
• Serve as facilitator and technical liaison for external laboratory testing (e.g., IEC 60601 electrical safety, EMC/EMI, environmental).
• Prepare and execute design verification tests (DVT) for hardware components and complete systems.
• Develop and maintain test procedures, test plans, test reports, and validation documentation in compliance with regulatory and QMS requirements.
• Maintain test equipment, verify calibration status, and ensure proper setup of fixtures, measurement devices, and diagnostic tools.
• Ensure compliance with relevant medical device standards (ISO 13485, IEC 60601 series, ISO 14971, etc.).
• Contribute to continuous improvement initiatives related to hardware quality, test processes, and product reliability.
• Prioritize and uphold high standards of security and data privacy in line with THORASYS policies.

Competencies and Qualifications

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field.
• Minimum 3 years of experience in hardware testing, validation, or reliability testing, preferably in medical devices or similarly regulated industries.
• Strong understanding of electronic circuits, sensors, embedded systems, and electromechanical devices.
• Experience operating and interpreting results from test equipment such as oscilloscopes, multimeters, signal generators, loads, and data acquisition tools.
• Knowledge of root cause analysis techniques (5 Whys, Ishikawa, fault tree analysis) and failure investigation methodologies.
• Familiarity with V&V processes for hardware and systems (verification protocols, traceability, documentation).
• Excellent communication skills; fluency in English and French (oral and written) required.
• Autonomous, methodical, organized, and detail-oriented.
• Legally authorized to work in Canada.

Additional Assets

• Experience working with EMC/EMI testing, electrical safety, or environmental chamber testing.
• Knowledge of IEC 60601, ISO 13485, ISO 14971, or similar regulatory frameworks.
• Experience with data analysis, statistical techniques, or reliability engineering concepts.
• Background in packaging/transport validation, including ISTA or equivalent standards.
• Understanding of firmware interactions with hardware (boot sequences, error handling, communication).
• Experience in a highly regulated industry (medical, aerospace, automotive, defense, etc.).
• Knowledge of documentation and change control systems (e.g. JIRA).

Job Type: Full-time, Permanent, on-site (Montreal)