Software Quality Engr II - Exempt

Job Overview

Join our dynamic team in Lafayette, CO, where innovation meets quality. Our mission is to ensure the highest standards in software systems for medical devices. We are looking for a dedicated professional to contribute to our cutting-edge projects and help us maintain excellence in the healthcare industry.

Responsibilities

As a key member of our team, your responsibilities will include :

• Collaborating with cross-functional teams to evaluate product definition requirements.
• Supporting new product development by updating and auditing Design History Files (DHF).
• Remediating design output documentation to meet intended use and performance criteria.
• Identifying potential design-related gaps and ensuring mitigation strategies are in place.
• Assessing test coverage and documenting remediation results with clear insights and recommendations.
• Following all Quality System Practices to ensure compliance with FDA, ISO, and European Medical Device standards.
• Developing and maintaining standards for software systems quality operating methods, processes, and procedures.
• Conducting evaluations of software systems activities, including requirements, design, development, and validation.
• Providing or directing verification and validation of software system requirements, traceability, and testability.

Required Skills and Experience

Nice to Have

Embrace the opportunity to work in a vibrant community in Lafayette, CO, where you can make a significant impact in the medical device industry. If you are ready to take on challenging projects and drive innovation, we encourage you to apply.