Job Description


Software Quality Engineer

US Citizen only
Contract Assignment- 6+ Months

 M-F 40 hours weekly


Our Client Medical Devices Group designs, manufactures, and distributes advanced infusion systems that improve medication safety, optimize application performance and reduce medical expenses. Our infusion and enteral products are used in both hospitals, at home, and in alternate care sites. Our electronic ambulatory infusion devices are complemented with advanced clinical software management tools, satisfying both clinical and operational requirements.

Essential Functions & Qualifications:

The Software Design Quality Engineer provides design quality engineering support to the design and development group for software development and design changes in support of Client’s infusion and enteral feeding pumps sold both in the US and internationally. This individual will have a critical role in fostering overall quality and ensuring compliance with regulatory requirements and international standards with respect to quality system, manufacturing, and medical device software.

Review and approval of software development lifecycle artifacts
• Compliance with FDA Quality System Regulation and international standards related to software, including IEC 62304
• Coaching functional groups in validation of manufacturing and quality system software
• Supporting global cross-functional development and/or maintenance projects
• Identify compliance gaps and work with Engineering to resolve compliance issues
• Identify improvement opportunities within the company Quality Management System (QMS)
• Support cross-functional projects to improve and maintain compliant, effective and efficient quality processes
• Foster and support a culture of quality throughout the Engineering organization
• Maintain up-to-date knowledge of regulatory requirements, international standards, and company QMS procedures for areas of responsibility
• Complete required training in a timely manner
• Other projects as assigned by management

Education and Experience:  

 B.S. degree in Computer Science or a closely related discipline from an accredited university
• Software development experience (requirement specification, design, implementation, test)
• QA or engineering/development experience in a regulated industry
• Experience in applying software development lifecycle and quality system principles, including Good Documentation Practices
• Working knowledge of regulatory requirements and international standards such as FDA Quality System Regulation, Medical Device Directive, ISO 13485, ISO 14971, IEC 62304, etc.




Software Quality Assurance/Engineer/Testing certification
• Strong interpersonal and communication skills (technical, non-technical, and cross-cultural)
• Excellent attention to detail and ability to consistently meet high standards of quality
• Proficiency in at least one of the following programming languages: C++, C#, Python
• Good organization and time-management skills, and ability to work simultaneously on multiple projects
• Proficiency using Microsoft Office tools: Word, Excel, PowerPoint and Outlook
• Experience in automated testing techniques and tools
• Understanding of risk management principles and practices
• Experience in collection and analysis of quality metrics
• Working knowledge of statistical methods

Application Instructions

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