We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

At Haemonetics, we are dedicated to our mission of improving patient care and advancing medical research. Our SafeTrace Tx software is critical to our transfusion management portfolio, providing comprehensive support for blood banks and hospitals. We are currently seeking a Principal and Lead Software Test Engineer to join our dynamic team.

As a Principal and Lead Software Test Engineer, you will play a crucial role in ensuring the quality and reliability of our SafeTrace Tx software. Responsibility for understanding and implementing the FDA process and the Verification and Validation (V&V) processes will be yours to drive. Demonstrative deep passion for and experience in testing automation for software, and adept at tracking quality metrics for the team to understand quality will be important. You will also have experience working with quality management systems. Proficiency in navigating and creating a trace matrix for a regulated software medical device is key.

These activities will be performed in an Agile software environment. The ideal candidate will be responsible for overseeing the technical aspects of all projects, providing technical guidance to development teams, and ensuring that the design, application, and maintenance of software meets the quality standards of Haemonentics and FDA regulations. If you are a highly experienced software engineer with a passion for innovation and a commitment to excellence in a regulated environment, we encourage you to apply for this exciting opportunity

• Lead the process of software testing for SafeTrace Tx, ensuring that our software meets the highest standards of medical device regulatory compliance and user satisfaction
• Lead our process for Verification and Validation (V&V) of the software medical device
• Develop and implement automated testing strategies for software products and maintain a deep passion for testing automation
• Establish, track, and report on quality metrics to provide the team with a clear understanding of software quality
• Leverage experience with quality management systems to ensure compliance with all relevant regulations and standards
• Create and navigate a trace matrix for SafeTrace Tx, ensuring clear documentation of the relationship between requirements and system test procedures
• Oversee the test design process for all products developed by Haemonetics in compliance with healthcare regulations including FDA requirements
• Provide technical guidance to development teams to mentor, guide, and train other engineers in regulations and compliance requirements, especially as it relates to testing software
• Establish and implement technical standards for testing software in compliance with all required healthcare regulations
• Recommend adjustments to resolve software issues and improve the functionality of existing software
• Diagnose, document, and troubleshoot systems to resolve problems identified through testing to successful resolution
• Implement strategies to improve the integration and efficiency of software testing
• Understand and implement agile methodologies in the testing process, ensuring efficient and effective testing activities
• Collaborate with various teams and stakeholders, including developers, QA engineers, and business leaders, to ensure comprehensive testing coverage in a regulated environment

• Bachelor's degree in computer science, Engineering, or a related field
• Minimum of 10 years of experience in software testing
• Firm understanding of the FDA process and the Verification and Validation (V&V) process
• Proven experience with testing automation software
• Experience with quality management systems
• Strong understanding of how to navigate and create a trace matrix for a regulated medical device
• Proven experience with agile development methodologies
• Strong analytical and problem-solving skills, with keen attention to detail
• Excellent communication and leadership skills, with the ability to drive consensus among diverse stakeholders

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