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

Job Description: 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 workstreams 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 workstreams 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

• 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 exposure to hazardous chemicals and biohazards
• Ability to comply with all appropriate job PPE requirements
• General office and HVAC noise

• 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 hours per day and/or 40 hours per week as business needs dictate
• This position may require occasional travel (<10%)
• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)

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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.