Senior Associate Scientist, IVD Test Dev

We are seeking a Senior Associate Scientist-IVD Test Development to support in‑vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR.

Title: Senior Associate Scientist, IVD Test Development

Location: On‑site, Cleveland, Ohio

Reports to: Sr Director, IVD Test Development

The Senior Associate Scientist will support in‑vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation in support of regulatory submissions such as PMA, 510(k), and IVDR. This role requires strong hands‑on technical skills, attention to detail, and the ability to follow established protocols while contributing to experimental planning and troubleshooting under the guidance of a supervisor.

• 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.
• Perform routine troubleshooting of assays, instrumentation, and laboratory workflows; resolve complex issues appropriately.
• Prepare reagents, solutions, and study materials while ensuring traceability and proper documentation.
• Demonstrate accountability for assigned work streams, meeting study timelines, documentation standards, and data quality expectations.
• Coordinate with vendors and internal teams to procure laboratory supplies and maintain operational readiness.
• Actively participate in technical discussions, team meetings, and cross‑functional reviews.
• Ensure compliance with all safety policies, biosafety procedures, laboratory standards, and company requirements.
• Other duties as assigned.

• Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 2–4 years of relevant experience.
• Master’s degree with 1–2 years of experience.
• Industry experience preferable.

• Hands‑on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling. (Experience with automated immunochemistry analyzers preferred).
• Ability to follow standard protocols and troubleshoot routine lab tasks.
• Experience with data analysis and documentation best practices.
• Familiarity working in an FDA or ISO‑regulated environment is a plus.
• Proficient with computer skills and Microsoft Office applications.

• Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation.
• Visual acuity to examine specimens and reagents.
• Offices reachable by elevator but must be able to climb stairs if needed.
• Light lifting may be required (up to 25 pounds).
• May be required to stand for long periods of time.
• Ability to operate a computer and other technology related lab equipment throughout the day.
• Ability to work in an environment with exposure to hazardous chemicals and biohazards.
• Ability to comply with all appropriate job PPE requirements.
• General office and HVAC noise tolerance.

• Full‑time on‑site position; this is not a remote position.
• This position is classified as exempt and may require work in excess of 8…