Manager Medical Device Software Engineer Jobs in Colorado

Company Description
Our medical technologies help make it possible for millions of people to resume everyday activities, return to work, and live better and longer. We're able to do this with the help of some very special people around the world: 38,000 dedicated employees who share a passionate purpose to improve lives, thousands of medical professionals who share their insights and ideas, and hundreds of advocacy associations that help us share information so people with debilitating diseases know relief is possible.
Job Description
This position is responsible for designing, developing and implementing methods of testing and troubleshooting ventillation and monitoring products and software under development, as well as those already established and undergoing design changes. The incumbent is a team member on project teams, interacting with members from Marketing, Quality, Regulatory, Engineering, Manufacturing, Service, as well as others required for the particular project. This position requires working knowledge and competency in software engineering and the desire to learn aspects of the other disciplines to facilitate growth into system-level testing and effectively communicate with those in other engineering disciplines.
This position supports products developed and manufactured by Covidien, specifically the Respiratory and Monitoring Solutions business. This position provides technical product test support for the Remote Patient Monitoring franchise
What is the work you will be doing?
Write clear, concise testing and engineering documents, including test protocols/procedures, test reports, as well as other communications to other parts of the organization.
Demonstrate ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.
Demonstrate competency with software application systems, web and database testing with desire to learn aspects of the other disciplines to grow as a system-level test engineer.
Work with other test engineers to design and/or develop testing methods and equipment to assure products meet requirements for performance and safety.
Work within project teams to complete product testing on time and within budget.
Perform regression analysis/testing and associated documentation on existing products undergoing change in design or manufacturing process.
Accurately estimate tasks and track/communicate progress for software verification and validation efforts
Maintain and manage processes to ensure that computer labs are setup, tested and ready for use
Review/Develop test plans to ensure that lab configurations meet requirements
Provide support for new project setup and troubleshooting for lab hardware, software, application
Investigate new technological developments to evaluate their potential advantages to the organization
Good writing, speaking and organizational skills essential
Qualifications
6+ years of technical testing experience in a structured and/or regulated (preferably medical device) product development or testing environment.
Knowledgeable and experience in software and hardware development and the processes associated with product life-cycles.
Knowledgeable and experience with automated requirements management tools such as Doors, Rational Requisite Pro, etc.
Knowledgeable and experience with defect tracking tools and procedures
Working knowledge and experience with software automation test tools and techniques such as TestComplete, Load Runner, QTP, etc.
Working knowledge of modern scripting languages as well as C# and .NET technologies
Working knowledge of database development and testing-SQL
Basic knowledge of networking--TCP/IP communications and understanding of routers and switches
Proficiency in installing and setting up desktops and servers
Experience managing and tracking software test efforts contracted to a third party vendor.
Prior knowledge of the FDA Quality System Regulation and/or ISO 13485 is a plus
Self motivated and able to work in a cross functional team environment
Good team player
Creative problem solver, ability to prioritize according to risk needs
Excellent written and verbal communication skills
Demonstrate level of technical competency in Engineering Software Testing discipline including application systems, web and database testing
Do you have these professional or academic certifications?
Bachelor of Science degree in Electronics Engineering, Computer Science, or Computer Engineering or other related technical field
Additional Information