Senior Data Scientist

Location: Remote (Must be authorized to work in the U.S.)

Hours: 15–20 hours/week

Client Industry: Medical Devices | Diagnostics | Digital Health

Overview:

We’re seeking a Senior AI/ML Consultant to support a cutting-edge medical device client working at the intersection of machine learning and real-time healthcare technology. This part-time, remote role is ideal for someone passionate about bringing AI-powered devices to life—whether it's imaging, diagnostics, or wearables.

Responsibilities:

• Lead the development of ML models for imaging analysis, signal processing, or device telemetry.
• Support model deployment strategies including edge computing or embedded ML for hardware integration.
• Guide regulatory-aligned development of AI models for SaMD (Software as a Medical Device) applications.
• Collaborate with engineering, quality, and clinical affairs teams to ensure model performance meets FDA/CE requirements.
• Provide technical documentation and validation support for 510(k), PMA, or EU MDR submissions.
• Drive innovation while balancing risk, safety, and compliance.

Requirements:

• 7+ years of experience in ML/AI, with 2+ years supporting medical device or digital health products.
• Expertise in computer vision, real-time ML inference, or signal processing.
• Proficient in Python, OpenCV, scikit-learn, and frameworks like TensorFlow or PyTorch.
• Familiar with FDA/IEC standards such as ISO 13485, IEC 62304, or FDA SaMD guidance.
• Experienced in working with multi-disciplinary engineering and regulatory teams.
• U.S.-based, with flexibility to work within East Coast collaboration hours.

Nice to Have:

• Background in biomedical engineering or computational imaging.
• Experience with embedded ML or mobile health platforms.
• Knowledge of cybersecurity and privacy in medical device AI.