Technical Software Project Lead

Gener8 | The RND Group; Indiana (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

Gener8 | The RND Group in Indianapolis, IN seeks a Technical Software Project Lead to guide software teams through FDA-regulated development. You will shape architecture, analysis, and customer-focused processes, coordinating multiple projects and mentoring engineers through all lifecycle stages.

A strong background in C#, C++, and software quality, plus knowledge of FDA 21 CFR Part 820 and IEC 62304, is essential.

Qualifications

• Must have a degree in computer science or related field with strong foundation in software engineering.
• Experience leading software teams in regulated environments and FDA contexts.
• Proven ability to manage projects, schedules, and budgets with minimal supervision.
• Excellent written and verbal communication skills for cross-functional stakeholders.
• Experience developing GUI applications and complex software systems.

Responsibilities

• Provide technical leadership for application software designs and development.
• Guide multiple projects and mentor engineers through lifecycle stages.
• Collaborate with SW and QA to ensure compliance with FDA regulations.
• Define software priorities and communicate requirements to the team and customers.
• Produce requirements specs and documentation for internal and external audiences.

Skills

Software leadership

Project management

Communication skills

Budgeting

Troubleshooting

GUI development

Regulatory experience

Education

MS/BS in Computer Science

Electrical Engineering

Tools

C#

WPF

SQL

XML

HTML

JavaScript

ASP.Net

C++

Job description

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

• 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.

Requirements

• An 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 one or more of the following technologies: 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

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.

Gener8 | The RND Group

5975 Castle Creek Pkwy N Dr, Ste 250

Indianapolis, IN 46250 317-841-8070

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