Systems Engineer – AI Medical Devices (Contractor)
About Us At Prenuvo, we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against "we caught it too late again". We are seeking a collaborative Systems Engineer to support the design, integration and validation of Prenuvo's AI-driven diagnostic software systems. You will play a key role in ensuring that our Software as a Medical Device (SaMD) products meet global regulatory standards while delivering clinical-grade performance and reliability. This role is a one-year contract term to start, with the possibility of renewal based on business needs. Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives! What You'll Do • Design and Development: Support the design, development and validation of SaMD systems in accordance with FDA, Health Canada and ISO standards. • Cross-Functional Collaboration: Work closely with ML scientists, software developers, clinical experts and regulatory teams to ensure system-level alignment across technical and clinical requirements. • System Architecture: Assist in defining, documenting and maintaining scalable, secure, and compliant system architectures for AI-enabled MRI software. • Requirements Management: Define and document system requirements, functional specifications and validation procedures ensuring full traceability throughout the design control process. • Risk and Safety: Conduct system-level risk assessments and manage risk mitigation activities tied to performance, safety and usability. • Verification & Validation: Contribute to the planning and execution of verification and validation (V&V) testing, ensuring traceability from requirements to performance metrics. • Regulatory Support: Provide technical documentation and evidence to support regulatory submissions (such as 510(k), IDE, Health Canada Class II) and audits. • Post-Market Support: Assist with sustaining engineering, change control and performance monitoring activities in alignment with Good Machine Learning Practice. What You'll Bring • A strong sense of accountability and teamwork. You take initiative, communicate clearly, and deliver on commitments in a cross-functional environment. • 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. Our Values First: we are Pioneers • Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding. Second: we are Platform-Builders • We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead – in a mindset of ownership and duty to our mission. Above all: we are Patients • We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work. What We Offer • 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 • The hourly rate for this role ranges from $43.27–$53 in local currency, depending upon experience and geographic location We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules. Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends with @prenuvo.com. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to [email protected]. Apply tot his job