The successful candidate will have success in managing projects that identify, design, implement, and deliver quality software applications integrated with various hardware and connected devices. The ability to work closely with customers, understand problems, and present quality solutions is required. The consistent ability to successfully interact with customers on a daily basis is vital to fulfilling the role.
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 Project Manager/Technical Lead responsibilities include, but are not limited to, PC and microprocessor based software development, software/hardware integration, writing correspondence and documentation, system verification and validation, and customer interaction and training.
The position requires planning and executing multiple projects at one time and successfully guiding and reviewing other engineers through all phases of the project’s development. Successfully interacting with the customer’s management and closely managing the project’s profitability is also required. Occasional overnight travel may be required during critical periods of a project.
Required Skills and Qualifications:
- A MS/BS in Computer Science, Electrical Engineering or related field
- Minimum of 15 years’ experience
- Demonstrated leadership and project management skills
- Excellent oral and written communication skills
- Ability to tackle complex development tasks with minimal supervision
- Experience in developing Graphical User Interfaces
- Experience with serial communications or TCP/IP
- Developing software to control FDA Class 2 and 3 devices is a plus
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.
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