Scope: Contributes knowledge of IVD lateral flow product development and expertise to ongoing research and development and/or development activities of new lateral flow project proposals. Familiarity with PCR and other lateral flow technologies. Experience with IVD testing instrumentation for moderate complexity to CLIA waived devices from feasibility to verification. Independently designs, executes and interpret complex experiments and analytical procedures to address specific R&D related scientific objectives. Understanding of FDA 510k process, experience in writing Analytical study protocols and reports, QSR design control, experience in writing, submitting and post-submission FDA Q&A for 510k.
May perform some or all of the following:
Under supervision, performs analytical procedures and implements new techniques for lateral flow product development
Contributes to scientific literature, external conferences and/or scientific patents where applicable.
Provides consultation within and among internal groups.
Interpret and report results in oral and written formats, both within and outside the department.
Work simultaneously on several aspects of a project or multiple projects.
Education / Experience:
BS (Chemistry/Biology) with 2-5 years’ experience. IVD experience is a preferred.
Expertise in PCR assay development.
Understanding basic function of IVD product development under Design control
Familiar with Quality Systems and QSR compliance for documentation
Experience in 510(k) writing, submission, Q&A process
Knowledge of CLSI experimentation study protocols.
Skills / Pre-requisites:
Strong investigative or technological orientation with independence of experimental design
Proven track record of accomplishments in IVD lateral flow product development
Understanding of Statistical software packages Minitab or SAS JMP a plus
Prior knowledge of instrumentation a plus
Good work ethic, team player
Presentation, written and oral communication skills.
Company policies and Standard Operating Procedures as defined by QA system at the relevant Sekisui Diagnostics site.
Six Sigma training (a plus)