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.
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.
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.