Data Scientist – Medical Devices

Role: Data Scientist – Medical Devices Location: Remote Duration: 5+ Months Contract: W2 We are seeking an experienced Data Scientist with a strong background in Medical Device Quality Systems, Manufacturing Data Analytics, and AI/ML solutions to support advanced analytics initiatives in a regulated environment. Key Responsibilities: • Extract and integrate data from SAP, QMS platforms, MES systems, and service databases • Develop Python and Databricks pipelines to transform unstructured data such as complaints, CAPAs, NCRs, and quality reports into structured datasets • Design, implement, and optimize AI/ML workflows to identify quality trends, manufacturing issues, defect patterns, and root causes • Leverage LLM technologies, including Claude AI, to automate data extraction, event classification, and multi-step analysis • Build scalable analytics solutions that support quality investigations, regulatory compliance, and operational excellence • Ensure traceability, audit readiness, and compliance with FDA and Medical Device industry requirements • Collaborate closely with Quality, Manufacturing, Regulatory Affairs, and Engineering teams to drive actionable insights Required Qualifications: • 7+ years of experience working with Medical Device Quality Management Systems (QMS) • Strong experience with CAPA, NCR, Complaint Handling, and Quality Event Management • Deep understanding of FDA regulations and Medical Device compliance requirements • 7+ years of Data Science and/or Data Engineering experience • Expertise in Python, Databricks, and large-scale data ingestion and processing • Experience building advanced analytics solutions for: • Quality data • Manufacturing data • Failure analysis • Defect detection and trend analysis • Experience developing and deploying AI/ML models in regulated environments • MES (Manufacturing Execution Systems) experience Preferred Qualifications: • Experience integrating and deploying Large Language Models (LLMs) • Hands-on experience with Claude AI or similar GenAI platforms • Experience with Agentic AI workflows and intelligent automation solutions