Job Description:

The successful candidate will have experience working leading software development teams through a regulated environment. The Technical Software Project Lead has competency in software architecture and design, requirements analysis and customer focus. The consistent ability to successfully interact with RND customers daily 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 Technical Software Project Lead should be comfortable in application development, cloud development and/or embedded software development. The position requires planning and often executing multiple projects at one time and successfully guiding and reviewing other engineers through all phases of the project’s development.

Responsibilities

• Ensure software architecture and design aligns with user and client needs to bring high-value products to market.

• Leverage expertise in investigation and resolution of technical problems within the department.

• Translate written requirements into a well-designed implementation.

• Work with team members to understand customer needs and develop high value, fully integrated solutions for medical devices.

• Design and develop software supporting medical devices, in compliance with FDA regulations (FDA 21 CFR Part 820 – Quality System Regulation and IEC 62304 Software Development Lifecycle) and processes.

• Design software in conformance with current industry object-oriented guidelines and design patterns used in the existing software.

• Implement software requirements and designs using Qt, C++, and possibly C#. Review software developed by other team members.

• Perform activities including PC and microprocessor-based software development, software/hardware integration, written correspondence, and documentation.

Requirements

• A BS in Computer Science, Electrical Engineering, or related field

• Minimum of 5 years experience

• Excellent oral and written communication skills

• Demonstrated success in collaborating in a fast-paced team environment and delivering high-quality software products using established agile development methodologies against formal schedules

• Strong ability to multitask, prioritize, and meet deadlines

• Haven proven ability to self-manage, as well as manage interdisciplinary relationships

• Be customer-focused, team-oriented, and motivated, taking ownership of assigned tasks

• Experience with some or all the following technologies: Qt, C++, C#, WPF, SQL, XML, HTML, JavaScript, ASP. Net

• Knowledge and experience with cloud application development

• Experience in developing Graphical User Interfaces using Qt

• Experience designing and implementing software quality patterns and practices (continuous integration, static analysis, unit testing, integrated testing)

• Experience developing software for hardware

• Proof of troubleshooting skills is a plus

• Experience with serial communications or TCP/IP is a plus

• Experience developing medical device software is a plus

About RND

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.