FDA-Regulated Medical Software Project Lead

Gener8 | The RND Group; Indiana (PA); On-site; USD 140,000 - 190,000; Full time

Job summary

Gener8 | The RND Group is seeking a Technical Software Project Lead to guide software teams in a regulated FDA environment. You will own architecture, design, requirements analysis and customer interaction for medical device software (Class II/III).

You will manage multiple concurrent projects across application, cloud and embedded domains, mentoring engineers and ensuring delivery within FDA and IEC 62304 standards.

Qualifications

• 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.
• Ability to create and track a project budget and timeline.
• Excellent troubleshooting skills.
• Experience with C#, WPF, SQL, XML, HTML, JavaScript, ASP.Net.
• Experience in developing Graphical User Interfaces.
• Medical device experience is a plus.
• Experience in developing software to control FDA Class 2 and 3 devices is a plus.

Responsibilities

• Capable of working at a high level of performance on multiple projects and activities that dramatically impact the business.
• Provide technical leadership for application software designs and development to be used in medical diagnostic devices (both class II and III).
• Work with other technical leads on the design and development of application software and system-level software.
• Reliably manage high-quality software within schedule and budget constraints.
• Interacts with the SW and QA engineers to ensure that software products are robust, of very high quality, and meet FDA regulations (FDA 21 CFR Part 820 – Quality System Regulation and IEC 62304 Software Development Lifecycle).
• Implement software design efficiently in current programming languages (C#, C++, etc.).
• Proficient use of appropriate tools and techniques for productivity and code quality: debuggers, profilers, unit testing, source control, etc.
• Participate in the full life cycle of development, from specification and design through implementation, testing, and support.
• Define software development priorities and communicate software requirements with the development team and customers.
• Write software requirements specifications and software documentation for internal and external audiences.

Skills

Leadership

Project Management

Communication

Troubleshooting

Budget & Timeline

Multi-project Leadership

Education

CS/EE degree

Tools

C#

WPF

SQL

XML

HTML

JavaScript

ASP.Net

Job description

Gener8 | The RND Group is seeking a Technical Software Project Lead to guide software teams in a regulated FDA environment. You will own architecture, design, requirements analysis and customer interaction for medical device software (Class II/III).

You will manage multiple concurrent projects across application, cloud and embedded domains, mentoring engineers and ensuring delivery within FDA and IEC 62304 standards.