Systems Engineer – AI Medical Devices (Contractor)

Prenuvo • Redwood City, CA

19d • $43 - $53

About The Position

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!

Requirements

• 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.

Responsibilities

• 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.

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

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 101-250 employees