THIS JOB IS NO LONGER AVAILABLE. THIS IS ARCHIVAL INFORMATION. Software Quality Engineer / Medical Device Group / C++ C# Python UT
Job Title: Software Quality Engineer
Client Department: Medical Devices Group
Work Site Address: Salt Lake City, UT 84123
Job Number: 6012
Max Pay Rate: 48.00
Start Date: ASAP
End Date: 6 Months
Position Type: Contract
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 infusion and internal 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.
Roles and Responsibilities
• Review and approval of software development life cycle 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
Qualifications and Education Requirements
• 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 life cycle 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
1) What is the level of proficiency w/ programming and Python that you have?
2) What experience in writing or running formal software testing do you have?
3) What is your experience in regulated industries or formal design control environments?
The Medical Devices Group designs, manufactures, and distributes advanced infusion systems that improve medication safety, optimize application performance and reduce medical expenses. Our infusion and internal products are used in both hospital, 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.
Salt Lake City, UT
1275 N MANASSERO ST
ANAHEIM, CA 92807