Prenuvo · 1 month ago
Systems Engineer – AI Medical Devices (Contractor)
United States
Contract
Remote
Entry, Mid Level
$43.27/hr - $53/hr
2+ years expPrenuvo is on a mission to transform healthcare through proactive health solutions. They are seeking a collaborative Systems Engineer to support the design, integration, and validation of AI-driven diagnostic software systems, ensuring compliance with global regulatory standards.
Health CareHealth DiagnosticsMedical
Responsibilities
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
Qualification
Required
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
Company
Prenuvo
Prenuvo offers whole body MRI screening - we provide deep insights for earlier detection.
51-200 employees
H1B Sponsorship
Prenuvo has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
Funding
Current Stage
Growth StageTotal Funding
$190MKey Investors
Felicis
2025-02-13Series B· $120M
2022-10-18Series A· $70M
2022-10-18Debt Financing
Leadership Team
Andrew Lacy
Founder and CEO
Raja Haddad
Chief Marketing Officer
Recent News
felicis.com
2025-12-29
EU Startup News
2025-12-03
Company data provided by crunchbase