Sr. Software Verification Engineer

Ingeus via Alexander Mann Solutions

Boulder (CO)

On-site

USD 85,000 - 110,000

Full time

14 days+

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Job summary

Ingeus via Alexander Mann Solutions is seeking a Test Engineer in Boulder, Colorado. This role focuses on designing, developing, and implementing testing methods for medical technologies, ensuring compliance with FDA regulations.

The ideal candidate will have over 6 years of testing experience, be knowledgeable in software and hardware development, and possess a Bachelor's degree in a related field. Strong communication and organizational skills are essential for this position.

Qualifications

6+ years of technical testing experience in regulated product development environment.
Experience with automated requirements management and defect tracking tools.
Working knowledge of software automation test tools and modern scripting languages.

Responsibilities

Write clear testing documents and support product testing.
Work with project teams to complete testing on time and within budget.
Maintain processes to ensure lab readiness and investigate technological developments.

Skills

Technical testing experience

Software and hardware development knowledge

Automated requirements management tools experience

Defect tracking tools knowledge

Software automation test tools proficiency

Scripting languages knowledge

Database testing

Networking knowledge

Desktop and server setup

Software test management

FDA Quality System Regulation knowledge

Communication skills

Education

Bachelor of Science in Electronics Engineering, Computer Science, or related field

Tools

TestComplete

Load Runner

QTP

Job 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 ventilation 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.