Data Scientist

Job Title: Data Scientist – Medical Device

Location: Remote (U.S.-Based)

Employment Type: W2 Contract

Duration: 5+ Months

Pay Rate: $45.00–$50.00 per hour (W2)

Good-Faith Pay Statement

The pay rate listed above represents a good-faith estimate of the compensation for this role. Actual pay will be determined based on experience, skills, qualifications, and other job-related factors consistent with applicable law. This range complies with applicable state and local pay transparency requirements, including those in Colorado, California, New York, Washington, and other jurisdictions with disclosure obligations.

Benefits

This is a W2 contract position. No employer-provided benefits are included with this engagement. Consultants are responsible for their own benefits coverage during the contract term.

Job Summary

We are seeking an experienced Data Scientist with a strong background in medical device quality systems and data engineering to support a remote contract engagement. In this role, you will extract and process data from enterprise systems including SAP, quality management systems (QMS), and service logs. You will design and deploy Python and Databricks pipelines to transform unstructured documents—such as complaints, corrective and preventive actions (CAPAs), and quality reports—into structured, audit-ready datasets. You will build and refine AI and machine learning workflows, including large language model (LLM)-driven pipelines, to automatically extract signals, classify events, and perform multi-step analysis across manufacturing and quality data. Outputs must meet regulatory traceability and compliance standards. You will collaborate closely with quality, manufacturing, and regulatory teams to translate analytical findings into root cause analyses, defect detection enhancements, and accelerated investigation cycles.

Responsibilities

• Ingest and extract data from enterprise platforms including SAP, QMS tools, and service log systems.
• Build and maintain Python and Databricks data pipelines to clean, normalize, and structure large volumes of unstructured quality and manufacturing documents.
• Design, develop, and refine AI/ML workflows—including LLM-based and agentic systems—to extract key signals, classify quality events, and automate multi-step analyses.
• Test, evaluate, and tune models and agentic systems to improve accuracy, traceability, and regulatory compliance of outputs.
• Ensure all analytical outputs are audit-ready and aligned with applicable FDA and regulatory requirements.
• Partner with quality, manufacturing, and regulatory affairs teams to interpret findings and translate insights into actionable improvements.
• Support root cause analysis, defect detection, and investigation cycle optimization through advanced data science techniques.
• Document methodologies, data lineage, and model decisions in a manner consistent with medical device quality standards.

Required Qualifications

• 7 or more years of experience in quality management systems (QMS) within a medical device environment.
• Demonstrated experience with CAPA processes, nonconformance reports (NCRs), and related quality documentation.
• Strong understanding of FDA regulatory expectations and medical device compliance requirements.
• 7 or more years of experience in data science and data engineering, including working with large-scale datasets.
• Advanced proficiency in Python for data processing, analytics, and model development.
• Experience building and managing data pipelines in Databricks.
• Proven track record building advanced analytics solutions using quality and manufacturing data, including failure analysis and defect trend detection.
• Experience integrating AI and ML models into quality or manufacturing workflows.
• Experience with Manufacturing Execution Systems (MES).

Preferred Qualifications

• Experience integrating large language models (LLMs) into production data or quality workflows.
• Familiarity with Anthropic’s Claude AI or similar LLM platforms.
• Experience with agentic AI system design and deployment.

Work Requirements

• This is a fully remote position open to candidates authorized to work in the United States.
• Candidates must be able to work core business hours in their respective U.S. time zone.
• Reliable high-speed internet and a secure, dedicated work environment are required.
• This position does not sponsor work visas at this time.
• Background screening may be required prior to engagement start, consistent with applicable law.

Equal Opportunity Employer

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable federal, state, or local law. We are committed to providing reasonable accommodations to individuals with disabilities throughout the application and employment process in accordance with the Americans with Disabilities Act (ADA) and applicable state and local laws. If you require an accommodation, please contact us at the application stage.

How to Apply

Qualified candidates are encouraged to apply by submitting a current resume that reflects relevant experience. We review applications on a rolling basis and will contact candidates whose backgrounds align with the position requirements.