Triton Medical Robotics is building a fully flexible medical robot that enables doctors to reach deep into human anatomy, aiming to disrupt flexible endoscopy and set a new standard in outcomes. The Senior Software Quality Engineer will ensure the quality and compliance of software systems used in these complex medical devices.
Requirements
- Strong understanding of IEC 62304, ISO 14971, and other relevant standards and regulations governing medical device software.
- Experience with software verification and validation methodologies, including test planning, execution, and reporting.
- Proficiency in risk management techniques and tools, with experience in conducting risk assessments.
- Prior experience in and understanding of systems engineering and robotic controls
- Cybersecurity experience
- Experience with medical device non-product software validation
- Experience working on roboticized surgical systems
Responsibilities
- Work closely with the product development team to develop software requirements and manage the quality of software used in a complex electromechanical robotic system.
- Develop and implement software quality plans, procedures, and policies to ensure adherence to quality standards.
- Conduct internal audits and assessments to identify areas for improvement and ensure compliance with QMS as relates to the area of software quality.
- Provide CAPA and audit support in the area of software quality.
- 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.
- Analyze test results and provide recommendations for corrective actions to ensure software meets specified requirements and quality standards.
- Ensure compliance with relevant regulations and standards, particularly IEC 62304, throughout the SDLC.
Other
- Bachelor's degree in Computer Science, Software Engineering, or a related field.
- Minimum of 5 years of experience in software quality assurance, preferably in the medical device industry.
- Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams.
- Attention to detail and strong analytical skills, with the ability to troubleshoot and solve complex problems.
- Small company or startup experience
