By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Position Summary:

ProteinSimple is part of the Protein Platforms division of Bio-Techne (NASDAQ: TECH). We're rethinking protein tools and helping thousands of researchers around the world resolve their protein analysis problems so they can reveal new insight into proteins and their role in disease.  Software is vital to our success in developing award winning bio-tech instruments for the life sciences industry.  Our product development team is making products that are drastically changing how scientists and researchers use tools to become more productive. Use your strong knowledge of quality assurance to expand the reliability of our instrument systems. You will collaborate with other engineers and scientists in the production of manufacturing applications, working with test automation designs, device communications, and complex data workflows.  We are offering an opportunity to work with state of the art software/hardware technologies amongst a very creative, motivated, and talented team.

This position is responsible for the design and execution of test solutions to verify protein analysis products as a medical device. Interfaces closely with other disciplines on project teams to ensure a seamless transition through software life cycle and that testing is comprehensive with respect to regulatory standards. Participates in creation software requirements  and provides up-front feedback on requirements testability.

Perform additional duties as assigned.

ESSENTIAL FUNCTIONS

Disciplined and detail-oriented; deliver robust, readable test documentation. Key contributor for software manufacturing test solutions: IQ, OQ, and PQ Document automation solutions for production: requirements, test plans, protocols, and reports. Engage in the software test lifecycle for medical devices; knowledge of standards: GAMP 5, FDA GMP Experience with FDA regulations for software validation and 21CFR compliance Ensure that all test activities are conducted in accordance with Quality System procedures Assist with the creation and review of test operating procedures, work instructions, and forms. Determination and sound technical judgment in problem solving, analytical techniques, develops new / creative test designs, and can work independently with little supervision Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job. Performs additional duties as assigned.