Systems Engineer – AI Medical Devices
Prenuvo
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $43 - $53 per hour
Job Level
JuniorMid-Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SaMD developmentAI/MLmedical imaging technologiessystem architecturerisk managementverification and validationtechnical documentationdesign controlsperformance monitoring
Soft skills
communicationdocumentationcollaborationproblem-solving