Qualifications
What You’ll Do
Support the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with medical device regulations and standards (such as ISO 13485, IEC 62304).
Collaborate with multidisciplinary teams including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance to ensure seamless integration of system requirements.
Coordinate and document the development of system architecture to ensure scalability, reliability, and compliance with safety and performance standards.
Define and document system requirements, functional specifications, risk management strategies, and validation procedures.
Conduct risk assessments and manage risk mitigation activities related to system safety and performance.
Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD.
Oversee verification and validation testing, ensuring traceability from requirements to system performance.
Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance.
Stay updated with technological advancements, industry trends, and evolving regulatory requirements for medical devices.
Develop design control documentation, including system requirements, design reviews, and traceability matrices.
Support post-market surveillance activities, including software updates, patches, and enhancements.
About the job
About Prenuvo
At Prenuvo, we are transforming healthcare by shifting from reactive "sick-care" to proactive health management. Our award-winning whole-body scan is quick (under 1 hour), safe (utilizing MRI with no ionizing radiation), and non-invasive (no contrast required). Our innovative blend of optimized hardware, software, and advanced AI, paired with a patient-centric approach in our clinics both domestically and globally, positions us at the forefront of preventive healthcare.
We are seeking a Systems Engineer to assist in designing and developing systems for AI-driven diagnostic tools, ensuring adherence to medical device regulations.
Join us in reshaping healthcare through innovative technology and collaborate with high-performing teams of experts dedicated to making a meaningful impact on people's lives!
About Prenuvo
Prenuvo is at the cutting edge of healthcare innovation, dedicated to enhancing patient outcomes through advanced diagnostic technology. Our mission is to empower individuals to take charge of their health with proactive screening solutions that are safe, efficient, and effective.