In Vitro Diagnostics Scientist/Engineer
Job Description
About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace & Defense, Biomedical & Life Sciences, Intelligence & Sensing, and Energy & Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for four of the last five years. Learn more at www.cfd-research.com
Key Responsibilities:
- Design, develop, and optimize in vitro diagnostic assays across immunoassay (ELISA, lateral flow, multiplex), molecular (PCR, isothermal amplification), and biosensor-based detection platforms
- Design, develop, and optimize inline sample preparation workflows for whole blood-to-plasma purification, including integration with downstream detection systems
- Drive analytical method development and optimization, including selection, characterization, and qualification of antibodies, reagents, and detection chemistries
- Apply design of experiments (DOE) and statistical analysis to systematically optimize assay performance parameters including sensitivity, specificity, precision, and accuracy
- Collaborate cross-functionally with engineering, manufacturing, regulatory affairs, and quality teams to support design transfer and product scale-up
- Lead troubleshooting and root cause analysis for assay performance issues across development and transfer phases
- Monitor the competitive IVD landscape, track emerging detection technologies, and engage with evolving FDA and international regulatory guidance
Required Qualifications:
- BS in Biology, Biochemistry, Biomedical Science, Chemistry, or a closely related field
- 5+ years of industry experience in in vitro diagnostics, assay development, or a related life sciences product development role
- Demonstrated experience maturing an IVD product from early-stage development through 510(k) clearance, including verification, validation, and regulatory submission support
- Hands-on experience with immunoassay development (ELISA, lateral flow, chemiluminescence, or multiplex platforms) and/or molecular diagnostic assay development (PCR, RT-PCR, isothermal amplification methods)
- Proficiency in clinical sample preparation, including handling and processing of whole blood, plasma, and other biological matrices
- Working knowledge of FDA regulatory frameworks for IVD products (510(k), PMA, EUA) and/or CE-IVD requirements
- Familiarity with CLSI guidelines (EP05, EP09, EP15, or equivalent) and their practical application to analytical and clinical validation studies
- Strong data analysis skills, including experience with DOE and statistical methods for assay optimization and performance characterization
- Excellent technical writing skills with meticulous attention to documentation, SOPs, and DHF requirements
- Ability to obtain and maintain a security clearance is required
- Ability to work on site at headquarters in Huntsville, AL is a must.
Preferred Qualifications:
- MS in Biology, Biochemistry, Biomedical Engineering, or a closely related field
- Experience with point-of-care (POC) or near-patient testing platform development
- Familiarity with biosensor-based detection technologies or novel detection chemistries
- Experience supporting design transfer to manufacturing and managing assay performance through scale-up
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers our Full-Time, permanent employee-owners a highly competitive insurance package, including medical, vision, and dental insurance. Additionally, we offer company paid leave, compensation time, parental leave, long-term and short-term disability, accidental death and dismemberment, and life insurance. Part-Time and Temporary employee-owners may receive partial or reduced benefits and leave time based on their employment status level. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.
CFD Research is an EO employer - Veterans/Disabled and other protected categories