Software Quality Engineer

Job Description

BrioHealth Solutions Inc. is seeking a Software Quality Engineer to support design quality efforts for an active implantable medical device, covering both clinical and commercial needs in a GMP environment. In this role, you will be involved in every stage of the software development lifecycle, from requirements definition to post-market surveillance.

Responsibilities

1. Develop and execute comprehensive test plans to identify and mitigate software defects in Class III active implantable medical devices.
2. Lead and participate in test automation efforts to improve efficiency and coverage.
3. Collaborate with cross-functional teams including engineering, development, and regulatory affairs to ensure compliance with all relevant standards and regulations (e.g., FDA, ISO 13485).
4. Analyze test results, identify root causes of defects, and document corrective actions.
5. Participate in risk assessments and develop risk mitigation strategies for software.
6. Maintain a deep understanding of relevant medical device quality system regulations (QSRs) and standards.
7. Prepare, review, and maintain quality system documentation, including test plans, test cases, and reports.
8. Stay up to date on the latest advancements in medical device software testing.

Requirements

1. Minimum 5+ years of experience as a Software Quality Engineer in the medical device industry, with a strong focus on Class III active implantable devices.
2. Proven experience in developing and executing comprehensive test plans for medical device software.
3. In-depth knowledge of software development methodologies (e.g., Agile, Waterfall).
4. Experience with test automation tools and frameworks.
5. Strong understanding of risk management principles applied to medical device software.
6. Excellent analytical and problem-solving skills.
7. Superior written and verbal communication skills.
8. Ability to work independently and as part of a cross-functional team.
9. Familiarity with relevant medical device standards (e.g., IEC 62304, ISO 14971) is a plus.
10. Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) is a plus.
11. Experience with implantable medical devices.
12. Knowledge of FDA IDE regulations.
13. Familiarity with FDA complaint handling procedures during an IDE and post PMA.
14. Experience with Six Sigma or other quality improvement methodologies.

About BrioHealth Solutions Inc.

BrioHealth Solutions Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.