Senior Scientist, Verification & Validation - Diagnostics Platform

Nanopath Inc.; Cambridge (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Nanopath Inc. seeks a Senior/Principal Scientist to lead verification and validation for its in vitro diagnostic platform.

The role is hands-on, shaping requirements, protocols, experiments, statistics, and reports while collaborating with Engineering, Quality, and Regulatory to support design control and regulatory submissions. The candidate will drive analytical verification/validation, identify failure modes, and apply DOE and statistics to ensure robust performance for a women’s

Qualifications

• PhD or master's in bioengineering, biomedical engineering, molecular biology, chemistry, or related field with 5+ years of industry experience.
• Experience with verification and validation in regulated diagnostic product development.
• Familiarity with design control, quality systems, GLP/GxP principles, or documentation practices for regulated diagnostics.
• Experience with nucleic acid assays, biosensors, and/or microarrays.
• Highly organized with strong attention to detail and ability to complete tasks on time.
• Excellent communication and presentation skills.
• Collaborative, cross-functional team player with a passion for women’s health.

Responsibilities

• Lead analytical verification and validation activities for the diagnostic platform, including study planning, protocol development, execution, analysis, and reporting.
• Translate product requirements into verification and validation strategies, study designs, acceptance criteria, and risk-based testing.
• Identify, investigate, and resolve assay and process performance issues, including unexpected results and failure modes encountered during verification and validation.
• Apply statistical methods, DOE, and risk assessment tools to evaluate performance and support data-driven decisions.

Skills

Verification & validation

Design control

Quality systems

GLP/GxP knowledge

Communication skills

Education

PhD or Master's in bioengineering

Job description

Nanopath Inc. seeks a Senior/Principal Scientist to lead verification and validation for its in vitro diagnostic platform.

The role is hands-on, shaping requirements, protocols, experiments, statistics, and reports while collaborating with Engineering, Quality, and Regulatory to support design control and regulatory submissions. The candidate will drive analytical verification/validation, identify failure modes, and apply DOE and statistics to ensure robust performance for a women’s