Systems Engineer – AI Medical Devices (Contractor - USA)
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 looking for a Systems Engineer to support the design and development of systems supporting AI-driven diagnostic tools, ensuring they comply with medical device regulations. 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
- Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Computer Science, or a related field.
- Proven experience in system engineering for medical device development, specifically for SaMD.
- Must have strong knowledge of regulatory standards and frameworks for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Proficiency in system architecture design, risk management, and validation processes for SaMD.
- Familiarity with software development lifecycle (SDLC) methodologies, Agile processes, and DevOps.
- Experience with medical image processing, data security, and HIPAA/GDPR compliance is a plus.
- Experience implementing automation for software development, such as automated traceability, documentation generation, or CI/CD pipelines supporting verification and validation processes.
- Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.
- Strong communication skills, with the ability to translate complex technical information for cross-functional teams.
Nice To Haves
- Experience working with FDA and international regulatory bodies for medical device clearance.
- Familiarity with AI/ML development in healthcare.
- Understanding of medical device cybersecurity and risk management practices.
Responsibilities
- Support the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with relevant medical device regulations and standards (e.g., ISO 13485, IEC 62304).
- Collaborate with cross-functional teams, including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance, to ensure seamless integration of system requirements.
- Coordinate and document the development of system architecture that ensures scalability, reliability, and compliance with safety and performance standards.
- Define and document system requirements, functional specifications, risk management strategies, and validation procedures.
- Conduct risk assessments and manage risk mitigation activities related to system safety and performance.
- Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD.
- Oversee verification and validation testing, ensuring traceability from requirements to system performance.
- Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance.
- Stay current with technological advancements, industry trends, and evolving regulatory requirements for medical devices.
- Develop design control documentation, including system requirements, design reviews, and traceability matrices.
- Support post-market surveillance activities, including software updates, patches, and enhancements.
Benefits
- An avenue to make a positive impact on people's lives and their health
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What This Job Offers
Career Level
Mid Level
