Senior IVD Test Development Scientist

Cleveland Diagnostics, Inc.; Cleveland (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision for family

Retirement match

Paid time off

Stock option program

Job summary

Cleveland Diagnostics is seeking a Senior Associate Scientist for IVD Test Development to support in‑vitro diagnostic assay development and validation in a regulated environment with design control. The role includes executing experiments, data analysis, and contributing to PMA/510(k) and IVDR submissions and laboratory‑developed tests for internal clinical use.

The position emphasizes hands‑on technical skills, protocol adherence, and collaboration with supervisors and cross‑functional teams to

Qualifications

• Bachelor's degree in biology, Biochemistry, Molecular Biology, or a related field with 2-4 years of relevant experience.
• Master’s degree with 1-2 years of experience; industry experience preferable.

Responsibilities

• Design and plan laboratory experiments with clearly defined objectives and success criteria.
• Independently execute laboratory experiments supporting assay development, optimization, verification, and validation.
• Provide technical input toward refinement of new diagnostic assays and improvements to existing workflows.
• Apply basic to intermediate statistical analyses to study results and ensure data quality.
• Maintain GDP/QMS‑compliant records and documentation.

Skills

Lab techniques

Data analysis

Documentation

Troubleshooting

Microsoft Office

Regulated environment

Education

Bachelor's degree in biology/related

Master’s degree (preferred)

Tools

Pipetting

Automated immunochemistry analyzers

Scientific software

Job description

Cleveland Diagnostics is seeking a Senior Associate Scientist for IVD Test Development to support in‑vitro diagnostic assay development and validation in a regulated environment with design control. The role includes executing experiments, data analysis, and contributing to PMA/510(k) and IVDR submissions and laboratory‑developed tests for internal clinical use.

The position emphasizes hands‑on technical skills, protocol adherence, and collaboration with supervisors and cross‑functional teams to