Director Software Development

Job Description

Job Description

Director of Software

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. 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 the Project Leads through the software development 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 RND clients, project leads and ensure the project leads are meeting the Quality Objectives of RND.

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 (both class II and III).
• Give guidance to the project leads on the design and development of 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).
• Implement software design efficiently in current programming languages (C#, C , etc.).
• Proficiently use appropriate tools and techniques for productivity and 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.

Desired Skills and Qualifications

Experience in developing software to control FDA Class II and III devices.