Director, Software Development - Indianapolis - gener8

Description

Job Title: Director, Software Development ( Software Medical device, FDA Class II and III devices)

Reporting to: VP, Software and Indianapolis GM

Location: Indianapolis, Indiana

Job Site: On-Site

Job Description Revision Date: January 2026

Salary Range: 158, ,992 USD

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About us

Gener8 develops software to assist with our client's research and 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. Based on our expertise in developing medical device software, we provide assessments and remediation of our clients' quality management systems, software development life cycle processes, design history files, and other software-related deliverables.

The Software Director is responsible for leading Project Leads through the softwaredevelopment process. The Software Director has competency in software architecture, design, requirements, analysis, customer needs and project lead needs. The Software Director exhibits the consistent ability to successfully interact with Gener8 clients, project leads and ensure the project leads are meeting the Quality Objectives of Gener8.

Responsibilities

• Work at a high level of performance with project leads and guide their respective activities that dramatically impact the business.
• Give guidance on technical leadership for application software designs and development to be used in medical diagnostic devices.
• Provide guidance for the project leads to the design and development of safe, secure, application software and system-level software.
• Ensure the project lead is properly managing the development of high-quality software within schedule and budget constraints.
• Ensure that the Project Leads are in compliance with FDA regulations and expected standards (FDA 21 CFR Part 820 – Quality System Regulation and IEC 62304 Software Development Lifecycle).
• Ensure software design quality in current programming languages (C#, C++, etc.).
• Proficiently use appropriate tools and techniques for productivity and secure code quality: debuggers, profilers, unit testing, source control, etc.
• Give guidance to the project leads for all phases of the full lifecycle development, from specification and design through implementation, testing, and support.
• Ensure Project Leads are properly prioritizing software development priorities and communicating software requirements with the development team and customers.
• Act as a Project Lead on several projects concurrently, whether research applications or medical device regulated software.
• Serve as client facing Project Lead; as Business Analyst, QMS Compliance, Budget and Schedule focuses.

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.
• Experience in developing Graphical User Interfaces.
• Software Medical device experience.
• Software risk management experience.
• Experience in project leading software to control FDA Class II and III devices.

Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status. We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.

Company Benefits: Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.