Aicon biotech inc is a company that is invested by private shareholders and specialize in research, development, production and sales diagnostic reagents (rapid diagnostics) and IVD raw materials , research reagents, infectious disease protection supplies, etc. We have hundreds of partners worldwide.
Job Offers
IVD Development Scientist (Worksite: Aloha, OR)
An IVD Development Scientist is sought by a diagnostic medical device company headquartered
in Tigard, OR (Worksite in Aloha, OR) to perform the following three aspects of duties:
· Develop, optimize, validate and document new or existing IVD products in a regulated
environment (FDA-QSR, CLIA, CAP, ISO regulations)
· Conduct IVD product development activities with a focus toward 510(k) clearance or PMA
submission requirements.
· Manage and conduct performance qualification testing to support IVD product development
and FDA submission
· Develop SOPs, work instructions, study protocols and write technical reports to support FDA
submissions
· Establish and validate performance parameters, quality control, and stability specifications
for critical reagents
· Support the external and internal collaboration to process samples during development and
validation studies
· Design experiments for process characterization, performance qualification of equipment,
and development activities to support FDA submission
· Troubleshoot and enhance existing methods, improving assay capabilities and technical
robustness
· Maintain detailed, accurate, and accessible records of experimental data and present the
results at internal meetings
Required Skills and Qualities:
· PhD (or foreign equivalent) in Biochemistry, Bioengineering, Molecular Biology, or related
fields. Foreign equivalent acceptable
· 2+ years of experience in research and development, especially IVD diagnostic assay
development
· Demonstrated understanding of GMP, ISO, and Quality Systems.
· Familiarity with product/assay research, design, or development
· Excellent organization skills, communication and analytical skills
· Proficient in Microsoft Office to include Excel, Word, and PowerPoint.
Apply to AICON Biotech Inc. C/O Yanmei Lai 8194 SW Durham Rd, Tigard, OR 97224