Technical Software Project Lead

About the role

The successful candidate will lead software development teams in a regulated environment, with a focus on medical devices regulated by the FDA. This role requires expertise in software architecture, design, requirements analysis, and customer interaction. The Technical Software Project Lead must quickly learn FDA 21 CFR Part 820 – Quality System Regulation and IEC 62304 Software Development Lifecycle, and be comfortable with application development, cloud development, and/or embedded software development.

Responsibilities

• Provide technical leadership for application software designs and development used in medical diagnostic devices (both class II and III).
• Collaborate with other technical leads on the design and development of application and system-level software.
• Manage high-quality software development within schedule and budget constraints.
• Interact with SW and QA engineers to ensure software products are robust, high-quality, and compliant with FDA regulations (FDA 21 CFR Part 820 and IEC 62304).
• Implement software design efficiently using current programming languages (e.g., C#, C++).
• Use tools and techniques for productivity and code quality, such as debuggers, profilers, unit testing, and source control.
• Participate in the full software development lifecycle, from specification and design through implementation, testing, and support.
• Define software development priorities and communicate requirements with the development team and customers.
• Write software requirements specifications and documentation for internal and external audiences.

Requirements

• MS/BS in Computer Science, Electrical Engineering, or related field.
• Minimum of 15 years of experience.
• Demonstrated leadership and project management skills.
• Excellent oral and written communication skills.
• Ability to tackle complex development tasks with minimal supervision.
• Experience creating and tracking project budgets and timelines.
• Excellent troubleshooting skills.
• Experience with one or more of the following technologies: C#, WPF, SQL, XML, HTML, JavaScript, ASP.Net.
• Experience developing Graphical User Interfaces.
• Medical device experience is a plus.
• Experience developing software for FDA Class 2 and 3 devices is a plus.

About RND

RND is a highly specialized software engineering firm dedicated to the FDA-regulated medical device market. We partner with product development organizations to provide project management, requirements management, software engineering, and product testing services. RND develops software for next-generation medical device platforms and instruments used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and support healthcare research.

RND is located at 5975 Castle Creek Pkwy N Dr, Ste 250, Indianapolis, IN 46250.