Data Scientist – Medical Devices

Job Description

We are seeking an experienced Data Scientist with a strong background in the Medical Device industry to support quality, manufacturing, and AI-driven analytics initiatives.

The ideal candidate will work with data from SAP, QMS platforms, MES systems, and service databases to identify quality trends, failure patterns, and process improvement opportunities. This role involves developing Python and Databricks-based data pipelines, transforming complex quality records into structured datasets, and building AI/ML solutions to support investigations, defect detection, and root cause analysis.

• Key Responsibilities
• Analyze and integrate data from QMS, MES, SAP, and other enterprise systems.
• Build and maintain data pipelines using Python and Databricks.
• Develop analytics solutions for quality, manufacturing, and failure trend analysis.
• Support CAPA, NCR, complaint, and quality event investigations.
• Build AI/ML models to improve defect detection and quality monitoring.
• Ensure compliance with FDA regulations and medical device quality standards.
• Collaborate with Quality, Manufacturing, and Regulatory teams to deliver actionable insights.
• Required Qualifications
• 7+ years of Medical Device industry experience.
• 7+ years of Data Science/Data Engineering experience.
• Strong QMS experience, including CAPA, NCRs, complaints, and quality systems.
• Experience with Python and Databricks.
• Experience working with large manufacturing and quality datasets.
• MES experience.
• Strong understanding of FDA and regulatory requirements.

• Preferred Qualifications
• Experience with LLM integration and AI solutions.
• Experience with Claude AI or similar Generative AI platforms.
• Knowledge of agentic AI workflows and advanced analytics.