Senior IVD Test Development Scientist (On-Site)

Cleveland Diagnostics; Cleveland (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Cleveland Diagnostics Inc. in Cleveland, OH is seeking a Senior Associate Scientist-IVD Test Development to support regulated assay development and validation, including PMA, 510(k), and IVDR submissions.

The role requires hands-on lab work, data analysis, and documentation in a GDP/QMS-compliant environment, with emphasis on planning experiments, troubleshooting, and collaborating across teams.

Qualifications

• Bachelor's degree in biology, Biochemistry, Molecular Biology, or a related field with2-4 years of relevant experience.
• Master's degree with1-2years of experience
• Industry experiencepreferable

Responsibilities

• In collaboration with a supervisor, design and plan laboratory experiments with clearly defined objectives and success criteria.
• Independently execute laboratory experiments supporting assay development, optimization, verification, and validation in accordance with approved protocols and design control requirements.
• Provide technical input toward refinement of new diagnostic assays and improvements to existing assay workflows.
• Independently apply basic to intermediate statistical analyses to study results and ensure data accuracy and integrity.
• Prepare data summaries, figures, tables, and preliminary interpretations for internal technical review.
• Maintain complete, accurate, and GDP/QMS-compliant experimental records and documentation.

Skills

Pipetting and reagent preparation

Data analysis

Laboratory troubleshooting

Regulatory familiarity (FDA/ISO)

MS Office proficiency

Automated immunochemistry analyzers

Documentation and records

Education

Bachelor's degree in biology, Biochemistry, Molecular Biology, or a related field

Master's degree

Tools

Microsoft Office

Job description

Cleveland Diagnostics Inc. in Cleveland, OH is seeking a Senior Associate Scientist-IVD Test Development to support regulated assay development and validation, including PMA, 510(k), and IVDR submissions.

The role requires hands-on lab work, data analysis, and documentation in a GDP/QMS-compliant environment, with emphasis on planning experiments, troubleshooting, and collaborating across teams.