V&V Senior Scientist / Principal Scientist

The role

The Senior Scientist / Principal Scientist will lead verification and validation activities for the Nanopath diagnostic platform. This hands-on role focuses on assay integration, protocol development, and statistical analysis.

What you will do

• Lead analytical verification and validation activities including study planning, protocol development, execution, analysis, and technical reporting.
• Translate product requirements into verification and validation strategies, study designs, and risk-based testing approaches.
• Identify, investigate, and resolve assay and process performance issues.
• Apply statistical methods, design of experiments, and risk assessment tools to evaluate performance.
• Partner with Engineering, Quality, and Regulatory to support design control and regulatory submissions.

Required qualifications

• PhD or master’s degree in bioengineering, biomedical engineering, molecular biology, chemistry, or a related field
• 5+ years of relevant industry experience
• Experience with verification and validation in a regulated diagnostic product development environment
• Familiarity with design control, quality systems, GLP/GxP principles, or documentation practices for regulated diagnostics
• Experience with nucleic acid assays, biosensors, and/or microarrays
• Extremely well-organized, with a high level of efficiency, attention to detail, and motivation for completing tasks accurately and on time
• Excellent communication and presentation skills
• Experience in cross-functional and highly collaborative work environments

About the company

Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed. The company is headquartered at The Engine in the Kendall Square ecosystem.