In Vitro Diagnostics Scientist/Engineer at CFD Research Corporation

<div class="content-intro"><p><strong>About CFD Research:&nbsp;</strong>Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace &amp; Defense, Biomedical &amp; Life Sciences, Intelligence &amp; Sensing, and Energy &amp; 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.&nbsp;<strong>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&nbsp;<a href="https://www.cfd-research.com">www.cfd-research.com</a></strong></p></div><p><strong><span style="text-decoration: underline;"><span data-contrast="none"><span data-ccp-parastyle="heading 1">Key Responsibilities:</span></span></span></strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal" data-ccp-parastyle-defn="{&quot;ObjectId&quot;:&quot;c66ef6be-b785-5f4e-bbb9-1327dfc155ae|1&quot;,&quot;ClassId&quot;:1073872969,&quot;Properties&quot;:[201342446,&quot;1&quot;,201342447,&quot;5&quot;,201342448,&quot;1&quot;,201342449,&quot;1&quot;,469777841,&quot;Times New Roman&quot;,469777842,&quot;Times New Roman&quot;,469777843,&quot;Times New Roman&quot;,469777844,&quot;Times New Roman&quot;,201341986,&quot;1&quot;,469769226,&quot;Times New Roman&quot;,268442635,&quot;24&quot;,469775450,&quot;whitespace-normal&quot;,201340122,&quot;2&quot;,134233614,&quot;true&quot;,469778129,&quot;whitespace-normal&quot;,335572020,&quot;1&quot;,335559740,&quot;240&quot;,201341983,&quot;0&quot;,134233118,&quot;true&quot;,134233117,&quot;true&quot;,469778324,&quot;Normal&quot;]}">Design, develop, and optimize in vitro diagnostic assays across immunoassay (ELISA, lateral flow, multiplex), molecular (PCR, isothermal amplification), and biosensor-based detection platforms</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Design, develop, and optimize </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">inline sample preparation workflows</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;for whole blood-to-plasma purification, including integration with downstream detection systems</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Drive </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">analytical method development and optimization</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">, including selection, characterization, and qualification of antibodies, reagents, and detection chemistries</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Apply </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">design of experiments (DOE) and statistical analysis</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;to systematically optimize assay performance parameters including sensitivity, specificity, precision, and accuracy</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Collaborate cross-functionally with engineering, manufacturing, regulatory affairs, and quality teams to support </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">design transfer and product scale-up</span></span></strong></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Lead </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">troubleshooting and root cause analysis</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;for assay performance issues across development and transfer phases</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Monitor the competitive IVD landscape, track emerging detection technologies, and engage with evolving FDA and international regulatory guidance</span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li> </ul> <p>&nbsp;</p> <p><span style="text-decoration: underline;"><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">Required</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}"> Qualifications:</span></strong></span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">BS in Biology, Biochemistry, Biomedical Science, Chemistry, or a closely related field</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">5+ years of industry experience in in vitro diagnostics, assay development, or a related life sciences product development role</span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Demonstrated experience </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">maturing an IVD product from early-stage development through 510(k) clearance</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">, including verification, validation, and regulatory submission support</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Hands-on experience with </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">immunoassay development</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;(ELISA, lateral flow, chemiluminescence, or multiplex platforms) and/or&nbsp;</span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">molecular diagnostic assay development</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;(PCR, RT-PCR, isothermal amplification methods)</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Proficiency in </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">clinical sample preparation</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">, including handling and processing of whole blood, plasma, and other biological matrices</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Working knowledge of </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">FDA regulatory frameworks</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;for IVD products (510(k), PMA, EUA) and/or CE-IVD requirements</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Familiarity with </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">CLSI guidelines</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;(EP05, EP09, EP15, or equivalent) and their practical application to analytical and clinical validation studies</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Strong </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">data analysis skills</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">, including experience with DOE and statistical methods for assay optimization and performance characterization</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Excellent </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">technical writing skills</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;with meticulous attention to documentation, SOPs, and DHF requirements</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><strong><em><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}">Ability to obtain and maintain a security clearance is required&nbsp;</span></em></strong></li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><strong><em><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}">Ability to work on site at headquarters in Huntsville, AL is a must.&nbsp;</span></em></strong></li> </ul> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong"><br></span></span><span style="text-decoration: underline;"><span data-contrast="auto"><span data-ccp-charstyle="Strong">Preferred</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}"> Qualifications:</span></span></strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">MS in Biology, Biochemistry, Biomedical Engineering, or a closely related field</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Experience with </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">point-of-care (POC)</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;or near-patient testing platform development</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Familiarity with </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">biosensor-based detection technologies</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;or novel detection chemistries</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-ccp-parastyle="whitespace-normal">Experience supporting </span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">design transfer to manufacturing</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="whitespace-normal">&nbsp;and managing assay performance through scale-up</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li> </ul> <p><span data-ccp-props="{}">&nbsp;</span></p><div class="content-conclusion"><p><strong>Benefits: </strong>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.</p> <p><em><strong>CFD Research is an EO employer - Veterans/Disabled and other protected categories</strong></em></p></div>