Validation Engineer

About the role

We are seeking a highly skilled Validation Engineer to join our team for the development of remote monitoring software focused on monitoring the performance of medical displays in hospitals. The ideal candidate will have a strong background in software validation, medical device standards, and a keen eye for detail. This role involves ensuring that the software meets all performance, reliability, and regulatory requirements, ensuring the highest standards of quality for our healthcare clients.

Responsibilities

• Develop comprehensive validation plans based on project requirements and regulatory standards.
• Define validation strategies, protocols, and acceptance criteria for the remote monitoring software.
• Create detailed test protocols to validate software functionality, performance, and compliance.
• Develop test cases to cover all aspects of the software, including data collection, transfer, and display accuracy.
• Execute validation protocols and document results.
• Perform functional, performance, and reliability testing of the remote monitoring software.
• Validate data integrity and accuracy, ensuring correct performance metrics for backlight, calibration, sensors, and picture tubes.
• Identify, document, and track software defects using a defect tracking system.
• Work closely with development teams to analyze and resolve validation issues.
• Ensure software validation activities comply with relevant regulatory requirements and standards (e.g., FDA, ISO 13485).
• Maintain up-to-date knowledge of regulatory standards and incorporate them into validation processes.
• Collaborate with cross-functional teams, including developers, QA engineers, and product managers, to ensure software validation.
• Provide clear and concise reports on validation activities, results, and any issues identified.
• Continuously improve validation processes and methodologies based on feedback and lessons learned.
• Stay updated with the latest trends and best practices in software validation and medical device standards.
• Document all validation activities, including test protocols, results, and any deviations or issues encountered.
• Ensure comprehensive and accurate documentation for regulatory audits and reviews.
• Coordinate and support user acceptance testing with end-users and stakeholders.
• Gather and incorporate feedback from UAT to enhance software validation and quality.
• Train and mentor team members on validation processes, regulatory standards, and best practices.
• Share knowledge and promote a culture of quality and compliance within the team.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or a related field.
• Proven experience as a Validation Engineer, preferably in the healthcare or medical device industry.
• Strong knowledge of software validation methodologies, tools, and processes.
• Familiarity with medical device standards and regulations (e.g., FDA, ISO 13485).
• Experience with remote monitoring solutions and cloud platforms is a plus.
• Excellent problem-solving skills and attention to detail.
• Strong communication and collaboration abilities.
• Ability to manage multiple tasks and projects simultaneously.