Job Description

Salary:

General Accountability

The Test Team Lead is accountable for the planning, coordination, and execution of software and hardware verification and validation activities for regulated medical device systems, ensuring that software and hardware meet defined safety, quality, performance, and regulatory requirements throughout the product lifecycle.

This role is responsible for leading a team of testers, establishing and maintaining robust test practices and documentation, and ensuring full traceability between requirements, risks, and test outcomes using tools such as Jira and Jama in alignment with applicable medical device standards and regulations. The role also supports hardware test protocol development, hands-on hardware testing, and coordination of internal and external hardware testing activities, including collaboration with third-party laboratories and cross-functional engineering teams.

Duties and Responsibilities

Primary duties are as follows:

Lead, mentor, and supervise a team of software testers, providing direction, coaching, and performance feedback to ensure effective delivery of testing activities.
Develop, maintain, and execute V&V plans, test strategies, protocols, and reports in accordance with internal procedures and relevant medical device standards and regulations.
Define, document, and manage acceptance criteria and test cases in Jira and Jama, ensuring complete bidirectional traceability between requirements, risk controls, and executed tests.
Develop and execute test protocols to verify system performance and compliance.
Coordinate with external testing laboratories to manage testing schedules, documentation, and reporting.
Perform hands-on hardware testing and develop test protocols using laboratory equipment and measurement tools. Design and oversee the execution of manual and automated test suites, including functional, regression, integration, and system-level tests for medical device software.
Collaborate with clinical stakeholders to design and execute clinically relevant test scenarios that reflect real-world workflows, user needs, and patient safety considerations.
Ensure effective defect management, including logging, triage, prioritization, root cause analysis support, and verification of corrective actions.
Coordinate with software development, systems engineering, quality, clinical and regulatory teams to align test coverage with design inputs, risk assessments, and project schedules.
Prepare and maintain clear, accurate, and audit-ready test documentation to support design reviews, internal audits, and regulatory submissions.

Additional duties may be required at times, such as:

Contribute to the evaluation, selection, and implementation of test tools and automation frameworks to improve test efficiency, coverage, and repeatability.
Support training and onboarding of new team members and cross-functional partners in test processes, tools, and quality system expectations.
Participate in risk management activities by providing test input to hazard analyses, FMEAs, and verification of risk controls.
Assist in the planning and support of clinical evaluations, usability activities, and design validation from a testing perspective.
Provide technical input during change impact assessments, post-market investigations, and product improvement initiatives related to software behavior.
Perform other related duties as assigned to support departmental and organizational objectives.

Education

Bachelors degree in computer science, Software Engineering, Biomedical Engineering, or related field.

Key Attributes

Required:

Minimum of five (5) years of experience in software and/or system testing within the medical device or similarly regulated industry, including experience in a senior or lead role.
Demonstrated knowledge of medical device regulations and software lifecycle standards, including IEC 62304, ISO 13485, ISO 14971 and IEC 60601.
Strong hands-on experience with Jira and Jama (or equivalent ALM tools) for requirements management, test case management, defect tracking, and maintaining bidirectional traceability.
Practical experience with automated testing, including defining what to automate, working with automation frameworks, and integrating tests into CI/CD pipelines.
Proven ability to collaborate with clinical users or subject matter experts to translate clinical workflows and risks into meaningful, clinically relevant test scenarios.
Demonstrated leadership skills, including team coordination, mentoring, workload planning, and promoting a culture of quality and continuous improvement.
Excellent written and verbal communication skills, with a strong focus on clear, structured, and compliant documentation.

Desirable:

Experience with biocompatibility, sterilization, cleaning validation, and packaging testing.
Experience supporting third-party certification testing (CSA, UL, TV, etc.).
Knowledge of system integration and reliability testing methodologies.
Experience with imaging or therapy-based medical devices (e.g., MRI-guided, ultrasound-guided, or other image-guided systems).
Working knowledge of scripting or programming languages such as Python or C# to support automation and custom test tooling.
Familiarity with risk-based testing methodologies and requirements traceability matrices.
Demonstrated ability to identify process gaps and lead initiatives to improve test practices, efficiency, or compliance.
Strong interpersonal skills and the ability to influence cross-functional stakeholders in a highly regulated environment.

We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.

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.

Profound Medical

Open Positions

Test Team Lead