Scientist, IVD Test Dev

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

Title: Scientist, IVD Test Development

Location: On-site, Cleveland, Ohio

Reports to: Sr Director, IVD Test Development

The Scientist will contribute to in‑vitro diagnostic (IVD) assay development and validation efforts within a regulated environment operating under design control, working independently design and execute experiments to support assay optimization, verification, and validation activities for regulatory submissions including PMA, 510(k), and IVDR.

The Scientist role requires strong technical expertise in assay development, data analysis, and troubleshooting, with the ability to manage defined project work streams and timelines while collaborating cross‑functionally with R&D, Quality, Regulatory, and Manufacturing teams.

In addition to hands‑on laboratory responsibilities, this position is expected to provide technical guidance to junior team members and support method transfers and process improvements. The role may also involve handling human biological specimens such as blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.

• Plan and lead the design, execution, and analysis of assay optimization and validation studies with minimal supervision, including assessment of method limitations and risk.
• Author study protocols and reports to support regulatory submissions.
• Apply intermediate to advanced statistical analyses to evaluate assay performance, interpret results, and draw scientifically sound conclusions.
• Prepare high‑quality data packages, figures, tables, and integrated interpretations suitable for internal decision‑making.
• Ensure complete, accurate, and GDP/QMS‑compliant experimental documentation.
• Lead troubleshooting efforts for assay, instrumentation, or workflow challenges.
• Take ownership of defined work streams within the product development process, including scientific quality, timelines, risk management, and deliverables.
• Contribute to the development, review, and continuous improvement of SOPs, work instructions, and training materials.
• Actively participate in cross‑functional analytical discussions, design reviews, and project team meetings as a scientific contributor.
• Champion laboratory safety, quality, and compliance culture; ensure adherence to all safety policies, laboratory procedures, and company standards.
• Other duties as assigned.

• Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 8‑12 years of relevant experience.
• Master’s degree with 4‑8 years of experience.
• Ph.D. with 0‑2 years of experience.

• Extensive technical expertise in product development.
• Strong working knowledge of CLSI standards and demonstrated ability to translate guideline requirements into statistically sound study protocols and reports.
• Experienced at creating formal protocols and reports.
• Extensive experience optimizing and troubleshooting assays during development.
• Experience with statistical analysis software (Analyze‑It, JMP).
• Proficient computer skills especially with Microsoft Office applications.
• Commercial IVD product development experience preferred.

• 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 should 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 through course of day.
• Ability to work in an environment with…