Lab Technologist - IVD Validation & Compliance

Insight Global; Franklin Lakes (NJ); On-site; USD 48,216 - 55,104; Full time

Job summary

A leading consulting firm is seeking a lab specialist in Franklin Lakes, NJ, to support the development and validation of innovative in-vitro diagnostic (IVD) devices. The role involves ensuring product safety and compliance while collaborating with cross-functional teams. Candidates should have at least 5 years of laboratory experience and a Bachelor's degree. This is a contract position offering a competitive hourly rate.

Qualifications

• 5+ years of experience in a laboratory environment required.
• Experience with manual differential testing is essential.
• Familiarity with instrument validation/qualification for clinical labs is needed.

Responsibilities

• Support the design, testing, and reporting of new or updated IVD devices.
• Operate and maintain a variety of lab instruments and platforms.
• Lead and manage clinical studies and complaint investigations.
• Conduct Clinical Software Validations and instrument qualifications.
• Apply quality and regulatory standards to lab processes.
• Troubleshoot technical issues using scientific judgment.
• Work cross-functionally with various teams.

Skills

5+ years experience in a laboratory environment

Manual differential testing experience

Experience with new instrument validation/qualification

Education

Bachelor's Degree

Job description

A leading consulting firm is seeking a lab specialist in Franklin Lakes, NJ, to support the development and validation of innovative in-vitro diagnostic (IVD) devices. The role involves ensuring product safety and compliance while collaborating with cross-functional teams. Candidates should have at least 5 years of laboratory experience and a Bachelor's degree. This is a contract position offering a competitive hourly rate.