Senior Medical Device 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

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.