Systems Engineer – AI Medical Devices

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Prenuvo

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Prenuvo is a fast growing health tech company specializing in whole body diagnostic imaging. We are a global leader in whole body MRI screening with a track record of early detection of cancer and other major health diseases.In an era of reactive and fragmented health screening, Prenuvo is rooted in early detection through cutting-edge imaging technology. Our technology brings together comprehensive scans, AI-augmented analysis, and protocols that have been honed over years of research and practice. Together, Prenuvo’s scans offer unparalleled diagnostic accuracy for you and your doctor.We empower people to make informed decisions about their health by putting comprehensive, consistent, and detailed scans in your hands. Simply put, we offer you a window into your own body.Prenuvo is one of the first scans to use artificial intelligence to build consistent, reliable, and standardized reports for the radiologists interpreting your scans.We provide faster, easier access to the clinically-significant insights needed to make more informed health decisions. We do it to help people live longer, better, healthier lives. A more comprehensive picture of your body enables you to feel empowered and advocate for yourself.

51 - 200 employees

💰 Debt Financing on 2022-10

📋 Description

• Support the design, development and validation of SaMD systems in accordance with FDA, Health Canada and ISO standards. • Work closely with ML scientists, software developers, clinical experts and regulatory teams to ensure system-level alignment across technical and clinical requirements. • Assist in defining, documenting and maintaining scalable, secure, and compliant system architectures for AI-enabled MRI software. • Define and document system requirements, functional specifications and validation procedures ensuring full traceability throughout the design control process. • Conduct system-level risk assessments and manage risk mitigation activities tied to performance, safety and usability. • Contribute to the planning and execution of verification and validation (V&V) testing, ensuring traceability from requirements to performance metrics. • Provide technical documentation and evidence to support regulatory submissions (such as 510(k), IDE, Health Canada Class II) and audits. • Assist with sustaining engineering, change control and performance monitoring activities in alignment with Good Machine Learning Practice.

🎯 Requirements

• Minimum of 2 years of experience in medical device development, ideally including Software as a Medical Device (SaMD) or other regulated digital health systems. • Knowledge of AI/ML and medical imaging technologies required. • Working knowledge of regulatory and quality frameworks, including FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. • Experience supporting design controls, risk management and verification & validation activities in a regulated environment. • Ability to translate complex technical details into clear documentation and communicate effectively with non-technical stakeholders. • Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Computer Science, or a related discipline.

🏖️ Benefits

• An avenue to make a positive impact on people's lives and their health • Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way • Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize