Systems Engineer • Mid-Level

Who you are

You have a background in systems engineering with experience in developing software as a medical device (SaMD) solutions — your understanding of medical device regulations like ISO 13485 and IEC 62304 ensures that you can navigate compliance effectively. You are skilled in Python and have a solid foundation in machine learning principles, allowing you to collaborate with ML scientists and software developers seamlessly.

You possess strong analytical skills and are adept at conducting risk assessments — your ability to manage risk and develop validation procedures is crucial in ensuring the safety and performance of medical devices. You thrive in collaborative environments, working closely with clinical experts and regulatory affairs teams to integrate system requirements effectively.

What you'll do

As a Systems Engineer at Prenuvo, you will support the design, development, and validation of AI-driven diagnostic tools — your role will involve ensuring that all systems comply with relevant medical device regulations and standards. You will coordinate the development of system architecture that guarantees scalability and reliability, while also documenting system requirements and functional specifications.

You will conduct risk assessments and manage risk throughout the development process, ensuring that all safety and performance standards are met. Collaborating with cross-functional teams, you will help integrate system requirements and contribute to the overall mission of transforming healthcare through proactive solutions.

What we offer

At Prenuvo, you will be part of a mission-driven team dedicated to reshaping healthcare — we offer a dynamic work environment where innovation is encouraged, and your contributions can make a real difference in people's lives. You will have the opportunity to work with cutting-edge technology and high-performing teams, gaining valuable experience in the healthcare technology sector. We believe in fostering a culture of collaboration and continuous learning, providing you with the resources and support needed to excel in your role.