Scientist I

Integrated Resources Inc.; City of Rochester (NY); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company is seeking a candidate to join their multi-disciplinary team focused on medical device evaluation. The position involves analyzing tests on clinical chemistry and related instruments, ensuring compliance with regulations, and collaborating with various technical specialists. This role requires a bachelor's degree in a relevant field and offers an opportunity for recent graduates or professionals looking to expand their expertise in the medical device industry.

Qualifications

• 0-4 years’ experience in clinical chemistry, biochemistry, biotechnology, medical technology, biology, or chemistry.
• Knowledge of FDA 510k’s and design control process for Medical Devices.
• Experience in laboratory environments troubleshooting instruments is a plus.

Responsibilities

• Run and analyze Medical Device evaluation tests on various instrumentation.
• Ensure compliance with regulatory requirements and perform system testing.
• Interact with a multi-disciplinary team while maintaining clear communication.

Skills

Troubleshooting

Attention to detail

Communication

Education

BS in Clinical Chemistry

BS in Biochemistry Biotechnology

BS in Medical Technology

BS in Biology

BS in Chemistry

Job description

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.

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.

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.