Job Title: Sr. Quality Engineer, Software

The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxStage Medical, Inc. maintains the right to modify this list at any time.

Summary

This position applies software engineering and quality assurance principles and techniques to the software development and product development lifecycles, and performs software and system testing for NxStage medical devices and other business software that supports the Quality System. This position must work closely with the R&D (Research and Development) organization, IT (Information Technology), and other internal customers.

Specific Duties:

• Work with internal groups to guide the creation of project plans, requirements, test plans, and perform verification and validation testing required in an FDA-regulated environment.
• Assist project teams in assessing the required validation activities for software systems.
• Develop and execute procedures and scripts meant to test the performance of the following software:
• Software contained in NxStage commercially distributed products.
• Software used in the manufacture and/or testing of NxStage products.
• Software used in NxStage quality systems.
• Lead team reviews related to software validation
• Perform device system and performance testing in the lab.
• Develop testing strategies and software risk analyses.
• Coach project teams in good development, documentation, configuration management, and testing practices, and in the merits and necessity of software validation.
• Develop and implement continuous improvement activities related to the development of and configuration management of NxStage software.
• Develop and implement quality metrics associated with software development and performance.
• Responsible for monitoring regulatory environment and for making the necessary changes to NxStage procedures to ensure compliance.
• Perform other duties as assigned.

Requirements:

• Automated testing, both windows-based and embedded, is desired.
• Bachelors degree in computer related field.
• 7 years minimum related software quality assurance experience (experience in a medical device company preferred).
• Experience with requirements traceability desirable
• Working knowledge of FDA Quality System Regulation 21 CFR Part 820 preferred, as well as knowledge of software engineering standards.
• Good organizational, attention to detail and follow-through skills.
• Excellent verbal communication and customer interface skills.
• Ability to interface with multiple groups in the organization.
• Computer skills C++, C, object oriented design, embedded software design.
• Willingness to contribute to other departments as necessary.

NxStage Medical is an Equal Opportunity Employer

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