Scientist I

We are seeking a Scientist I to run and analyze compliant Medical Device evaluation tests on new clinical chemistry, immunochemistry, immunohematology, and blood donor instrumentation during integration, verification, validation, and customer validation. The candidate will work as part of a multi-disciplinary team and be responsible for troubleshooting, clear and concise communication, and attention to detail.

Requirements

• BS in Clinical Chemistry, Biochemistry, Biotechnology, Medical Technology, Biology, or Chemistry
• 0-4 years' experience in clinical chemistry, biochemistry, biotechnology, medical technology, biology, or chemistry
• Experience or knowledge of FDA 510k's and the design control process (Verification and Validation) for Medical Devices
• Experience or knowledge of evaluation and statistical analysis using methods such as the CLSI documents
• Experience in identifying and resolving problems for Medical Device instrumentation
• Experience working in a laboratory running and troubleshooting instruments
• Experience evaluation studies with Medical Devices