Job opening for Vice President of Software Development at iCardiac Technologies
Over the coming days and months I plan to post a fair bit about iCardiac Technologies, a new company I’m involved with that provides advanced cardiac safety analysis technologies for clinical trials. Think of it as a more sophisticated version of eResearch Technology. The company emerged from the Heart Research Follow-up Program at the University of Rochester and is the winner of the Frost & Sullivan Innovation of the Year Award for Cardiac Safety Analytics.
Right now they are seeking a Vice President of Software Development. Contact Mike Totterman [mikael DOT totterman AT icardiac DOT com] if you are interested.
The Vice President of Software Development is responsible for the software development operations of iCardiac Technologies. You will be overseeing a staff of algorithm developers, software developers and software testers to ensure that the companyÃƒÂ‚â€™s suite of products meet user requirements for analyzing electrocardiogram data from pharmaceutical clinical trials in determining a drugÃƒÂ‚â€™s cardio toxicity. Familiarity with structured software life cycle management systems (such as AAMI/ANSI SW:68) including use of standard operating procedures common in the medical software arena is a critical requirement for the position. Leadership experience in environments with strong quality systems such as those defined by the ISO guidelines such as ISO 9001:2000 or ISO 13485 or similar quality systems is important for the position. Additionally, the position requires comfort and understanding of FDA regulations including FDA 21 CFR part 820 as it pertains to design control in software development (or similar structured design control procedures), FDA 21 CFR part 11 for digital signatures as well as strong understanding of structured validation requirements as specified in FDAÃƒÂ‚â€™s Guidelines for Use of Computerized Systems in Clinical Trials.
- Bachelors or Masters degree in computer science with strong academic performance
- Previous experience in leading a software development team
- Strong understanding of software life cycle management processes
- Strong communication skills and ability to work with senior management to prioritize various software development projects to meet customer requirements and company financial goal
- Previous experience in FDA regulated software environments such as software development for clinical trials or software development for medical devices
- Experience with C++, C# as well as database programming
- Previous experience with quality systems as they relate to software development
- Ability to learn quickly, function independently and handle increasing levels of responsibility