Software Quality Engineer

at  BRIOHEALTH SOLUTIONS INC

JOB DESCRIPTION

BrioHealth Solutions Inc., 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 in the software development lifecycle, from requirements definition to post-market surveillance.

REQUIREMENTS

• 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.
• Proven experience in developing and executing comprehensive test plans for medical device software.
• In-depth knowledge of software development methodologies (e.g., Agile, Waterfall).
• Experience with test automation tools and frameworks.
• Strong understanding of risk management principles applied to medical device software.
• Excellent analytical and problem-solving skills.
• Superior written and verbal communication skills.
• Ability to work independently and as part of a cross-functional team.
• Familiarity with relevant medical device standards (e.g., IEC 62304, ISO 14971) is a plus.
• Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) is a plus.
• Experience with implantable medical devices.
• Knowledge of FDA IDE regulations.
• Familiarity with FDA complaint handling procedures during an IDA and post PMA.
• Experience with Six Sigma or other quality improvement methodologies.

• Develop and execute comprehensive test plans to identify and mitigate software defects in Class III active implantable medical devices.
• Lead and participate in test automation efforts to improve efficiency and coverage.
• 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).
• Analyze test results, identify root causes of defects, and document corrective actions.
• Participate in risk assessments and develop risk mitigation strategies for software.
• Maintain a deep understanding of relevant medical device quality system regulations (QSRs) and standards.
• Prepare, review, and maintain quality system documentation, including test plans, test cases, and reports.
• Stay up to date on the latest advancements in medical device software testing.