Systems Engineer – AI Medical Devices (Contractor - USA)

About Us

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!

What You'll Do

• 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.

What You'll Bring

• 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 Have

• 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.

Our Values First: we are Pioneers

• Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.

Second: we are Platform-Builders

• We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead – in a mindset of ownership and duty to our mission.

Above all: we are Patients

• We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work.

What We Offer

• An avenue to make a positive impact on people's lives and their health
• The hourly rate for this role ranges from $48-$58 in local currency, depending upon experience and geographic location

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules. Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends with @prenuvo.com. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to [email protected]. Apply tot his job Apply To this Job