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
Required
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, Blazor, SQL, XML, HTML, JavaScript, ASP.Net
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