Senior Software Quality Assurance Engineer

2 months ago

Burlingame, California, United States Triton Medical Robotics Full time
About the Role

Triton Medical Robotics, a pioneering medical device startup, is seeking a highly skilled Senior Software Quality Assurance Engineer to join our team. As a key member of our software development team, you will play a crucial role in ensuring the quality and compliance of our software systems used in complex medical devices.

Key Responsibilities
  • Software Quality Assurance: Collaborate with the product development team to develop software requirements and manage the quality of software used in our electromechanical robotic system.
  • Quality Planning and Control: Develop and implement software quality plans, procedures, and policies to ensure adherence to quality standards.
  • Internal Audits and Assessments: Conduct internal audits and assessments to identify areas for improvement and ensure compliance with our Quality Management System (QMS) as it relates to software quality.
  • CAPA and Audit Support: Provide support for Corrective Action and Preventive Action (CAPA) and audit activities in the area of software quality.
Verification and Validation:
  • Test Planning and Execution: Plan, execute, and oversee software verification and validation activities, including test strategy development, test case creation, and test execution for product software and non-product software.
  • Test Result Analysis: Analyze test results and provide recommendations for corrective actions to ensure software meets specified requirements and quality standards.
Risk Management:
  • Risk Assessment and Mitigation: Participate in risk management activities related to software development, including hazard analysis, risk assessment, and risk mitigation planning per ISO 14971.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams to identify and address software-related risks throughout the product lifecycle.
Documentation and Reporting:
  • Documentation and Compliance: Prepare and maintain documentation related to software quality activities, including test plans, test reports, and compliance documentation.
  • Quality Metrics and Reporting: Generate periodic reports on software quality metrics, trends, and compliance status for management review.
Compliance Assurance:
  • Regulatory Compliance: Ensure compliance with relevant regulations and standards, particularly IEC 62304, throughout the Software Development Life Cycle (SDLC).
  • Regulatory Guidance: Review and interpret regulatory requirements related to software quality and provide guidance to the development team.
  • Industry Trends and Best Practices: Monitor industry trends, best practices, and regulatory updates related to software quality assurance and incorporate them into existing processes.
Continuous Improvement:
  • Process Improvement: Drive continuous improvement initiatives to enhance software development processes and increase efficiency and effectiveness.
Requirements
  • Education: Bachelor's degree in Computer Science, Software Engineering, or a related field.
  • Experience: Minimum of 5 years of experience in software quality assurance, preferably in the medical device industry.
  • Knowledge and Skills: Strong understanding of IEC 62304, ISO 14971, and other relevant standards and regulations governing medical device software.
  • Test Planning and Execution: Experience with software verification and validation methodologies, including test planning, execution, and reporting.
  • Risk Management: Proficiency in risk management techniques and tools, with experience in conducting risk assessments.
  • Communication and Collaboration: Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams.
  • Analytical and Problem-Solving Skills: Attention to detail and strong analytical skills, with the ability to troubleshoot and solve complex problems.

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