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