Validation Scientist

Validation Scientist

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Responsibilities:

• 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.
• The candidate will be responsible for thinking broadly and unconventionally, being open to new ideas from others, experience in good verbal and written communication, effective in multi-tasking and flexibility and will be required to deliver products on time.

Qualifications

• 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, 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.
• 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.