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Gener8 | The RND Group is seeking a Software Engineer with experience in PC and microprocessor-based software development and software/hardware integration. The role requires the ability to work with FDA-regulated medical device projects and to learn FDA 21 CFR Part 820 and IEC 62304 requirements.
Responsibilities include system verification/validation, documentation, and customer interaction. Strong communication skills and a background in GUI development are essential.
The successful candidate will have successful experience with projects that identify, design, implement, and deliver quality software applications integrated with various hardware and other connected devices. The ability to work closely with customers understand problems, and present quality solutions are required.
The majority of RND’s clients develop medical devices regulated by the FDA. The successful candidate will be able to quickly learn about FDA 21 CFR Part 820 - Quality System Regulation and IEC 62304 Software Development Lifecycle.
The Software Engineer’s responsibilities include, but are not limited to, PC and microprocessor-based software development, software/hardware integration, written correspondence and documentation, system verification and validation, and customer interaction and training, as necessary.
RND is a highly specialized software engineering firm dedicated to the FDA-regulated medical device market. We work with companies by partnering with their product development organizations in providing project management, requirements management, software engineering, and product testing services as needed to complement our clients’ existing engineering departments.
RND develops software to assist with our client's Next Generation medical device platforms and instruments. These platforms and instruments provide "breakthrough" technologies that are used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and perform research to assist with developing other healthcare solutions.
5975 Castle Creek Pkwy N Dr, Ste 250
Indianapolis, IN 46250 317-841-8070