[Hiring] Systems Engineer – AI Medical Devices @Prenuvo

Role Description

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!

• 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.

Qualifications

• A strong sense of accountability and teamwork.
• 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.
• The hourly rate for this role ranges from $43.27–$53 in local currency, depending upon experience and geographic location.