Clinical AI Medical Device Validation Specialist

Job Description

Job Description

Job Summary

Patfoci Technologies Inc., a leading innovator in AI-powered medical devices, is seeking a Clinical AI Medical Device Validation Specialist to join our Rochester team. This unique role blends clinical understanding, medical device expertise, and AI technology knowledge to ensure our devices, including the OxiGenius™ PPG AI Platform, meet rigorous regulatory, safety, and performance standards. The ideal candidate will help bridge the gap between clinical application and cutting-edge AI-driven diagnostics.

Responsibilities

• Design, implement, and manage clinical validation protocols for AI-based medical devices.

• Conduct detailed testing to verify device accuracy, reliability, and compliance with FDA and ISO 13485 standards.

• Analyze clinical data and generate comprehensive reports for regulatory submissions.

• Collaborate with product engineers and data scientists to refine algorithms based on clinical insights.

• Train internal teams on clinical validation procedures and regulatory requirements.

• Continuously review and improve validation processes to ensure patient safety and device efficacy.

Qualifications

• Bachelor’s degree or higher in Biomedical Engineering, Clinical Engineering, or related field.

• 3+ years of experience in clinical validation or regulatory compliance in the medical device industry.

• Hands-on experience with AI-based diagnostic devices preferred.

• Strong understanding of FDA regulations, ISO 13485, and clinical trial protocols.

• Excellent analytical, problem-solving, and documentation skills.

• Ability to work collaboratively across engineering, clinical, and regulatory teams.

Benefits

• Competitive salary and performance-based bonuses.

• Health, dental, and vision insurance.

• 401(k) with company match.

• Paid time off, including vacation and sick leave.

• Professional development opportunities, including training in AI and medical device regulations.

• Work in a cutting-edge, collaborative, and innovative environment.

About Patfoci Technologies Inc.

Founded in 2019 and headquartered in Rochester, Minnesota, Patfoci Technologies Inc. develops AI-driven medical devices that enhance healthcare accessibility and diagnostic accuracy. Our flagship OxiGenius™ PPG AI Platform measures over 15 digital biomarkers, including heart rate, blood pressure, SpO2, and sleep apnea detection, using advanced edge AI technology. Our mission is to democratize healthcare by providing accurate, real-time, and personalized diagnostic solutions worldwide.