Senior Scientist-IVD Test Development

Company: Cleveland Diagnostics Inc.
Location: Cleveland
Posted on: June 1, 2025

Job Description:

Our team is growing, and we currently have an immediate opening for an Senior Scientist- IVD Test Development




Title

Senior Scientist-IVD Test Development



Location

Onsite-Cleveland Office



Reports To

Sr Director, IVD Test Development



Job Overview


We are seeking a highly skilled Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead complex research projects and drive scientific innovation. The successful candidate will manage product Validation & Verification studies supporting PMA, 510K, and IVDR approval, working in a regulated environment under design control. This role involves project timeline management, data interpretation, and mentorship of junior scientists. The position may also require handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.




Essential Duties & Responsibilities


Lead project studies supporting regulatory filings, working on multiple unrelated projects simultaneously
Train and mentor junior scientists, fostering a culture of scientific excellence
Execute and document product development work under design control and the company's quality management systems, policies, and procedures
Develop and optimize study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory agency requirements
Perform complex statistical analyses independently or in coordination with statisticians
Interpret experimental results, draw conclusions, and define next steps to achieve project objectives
Ensure analyses and result interpretation are accurate and appropriate to support internal reports regulatory submissions, and scientific publications
Prepare clear, concise, and professional study reports to support regulatory submissions
Develop and deliver data-driven presentations for internal and external stakeholders
Create presentations to effectively communicate key research findings and project status
Lead technical discussions and project meetings, ensuring alignment with strategic goals
Ensure compliance with all safety and company policies, including biosafety and hazardous material handling protocols
Perform all other duties as assigned


Qualifications


Education & Experience:



Bachelor's degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 16-20 years of relevant experience


Master's degree with 10-15 years of experience


Ph.D. with 7-12 years of experience



Technical Skills:


Extensive technical and managerial expertise in IVD product development


Experienced at creating protocols and reports suitable for regulatory submission



Strong understanding of FDA and global regulatory requirements

Experience with statistical analysis software (Analyze-It, JMP)

Commercial IVD product development experience preferred




Leadership & Analytical Skills:

Demonstrated ability to lead research teams and manage multiple projects effectively
Strong data analysis and statistical interpretation skills
Ability to troubleshoot complex technical issues and drive problem-solving initiatives


Communication & Collaboration:

Proven ability to develop high-impact scientific reports, publications, and presentations
Excellent verbal and written communication skills, with experience presenting to diverse audiences
Strong interpersonal skills for mentorship and cross-functional collaboration






Physical Requirements/Working Conditions/Equipment used:


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




Other Requirements


COVID-19 vaccination is recommended

Full-time on-site position. This is not a remote position.


Position may require occasional travel (PIa38176d41601-25660-36861602

Keywords: Cleveland Diagnostics Inc., Euclid , Senior Scientist-IVD Test Development, Other , Cleveland, Ohio