Data Scientist (Post-Market Analytics Hub)

Position Title: Data Scientist (Post-Market Analytics Hub) Position Description 

Job Type:  Full Time Employee

Schedule:  Monday through Friday (no Holidays)

Location:  This position is 100% telework 

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; write detailed documents and reports; and execute other administrative tasks related to CDRH’s projects.

Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and applicable training in data analysis and computer science, as relevant to medical devices.

The contractor will support FDA CDRH post market surveillance and data modernization initiatives by developing advanced analytical solutions that integrate Medical Device Reports (MDRs), recalls, allegations, Unique Device Identifier (UDI), and registration/listing data into a unified analytical environment. Working closely with CDRH stakeholders, the individual will design and implement data pipelines, interactive dashboards, and signal detection tools that enable reviewers to independently access, visualize, and analyze post-market safety information.

Key Responsibilities:

• Develop and maintain data integration, ETL, and analytics solutions using Python, SQL, and related technologies
• Create self-service dashboards and data visualization tools using Tableau, Power BI, or similar platforms
• Support development of the Post-market Analytics Hub, providing integrated access to MDR, recall, allegation, and UDI data
• Perform safety signal detection, trend analysis, and data mining across multiple post market surveillance data sources
• Translate complex analytical findings into actionable regulatory insights and recommendations
• Collaborate with CDRH reviewers, scientists, engineers, and regulatory staff to improve access to post market safety information and support evidence-based decision making

Qualifications:

• The candidate must possess a Bachelor’s degree (BS) in engineering, computer engineering, or a related field
• An advanced degree (MS, PhD) in a related/applicable field is preferred
• Minimum 7 years of applicable experience is required
• Experience in post market surveillance analytics, adverse event and recall data, UDI systems, advanced analytics, data engineering, dashboard development, and medical device regulatory environments is highly preferred
• Strong communication skills and the ability to present technical findings to non-technical stakeholders are essential
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Must be a US Citizen or full Green Card holder.