Scientist 1 (Verification and Validation)

• The successful candidate, working as part of a multi-disciplinary team, will be responsible for running and analyzing compliant Medical Device evaluation tests on new clinical chemistry, immunochemistry, immunohematology and blood donor instrumentation during integration, verification, validation and customer validation.

• This work will include understanding how to run the analyzers as experts and understand when an analyzer runs correctly or does not.

• Troubleshooting skills are required.

• Clear and concise communication is key due to interacting with others in the lab and with the Evaluation Scientist.

• Testing accuracy (attention to detail) is of the highest need.

• Understanding the test designs and analysis is also required.

• System testing involves integrating assay clinical chemistry, immunochemistry and blood donor screening in a team setting where one is responsible for effectively interacting with people representing a broad array of technical specialties to achieve success.

• All work will be compliant with regulatory requirements, GCP and OCD procedures.

BS in Clinical Chemistry, Biochemistry Biotechnology, Medical Technology, Biology or Chemistry

• Exhibits core competencies 0-4 years’ experience in one of the following fields or related fields: Clinical chemistry, biochemistry, biotechnology, medical technology, biology and 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 is a plus.

• Experience working in a laboratory running and troubleshooting instruments.

• Experience evaluation studies with Medical Devices. Preferred:

• Experience working 510k’s on Medical Devices

• Experience setting up Medical Device evaluations internally or externally with customers. Experience with setting up Medical Device evaluations.

With Regards,

Devin Sharma

732-662-4561

Clinical Recruiter

Integrated Resources, Inc.