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About Us

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