||Principal Software Quality Engineer
As a key member of the Software Quality Group, the incumbent will support the process development activities related to the design, development, or reliability of NxStage Medical’s software-based products.
· Provides technical and statistical reliability support to Software Design, Manufacturing and Quality organizations
· Lead major efforts, or phases of projects, to resolve Software Quality-related problems
· Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed
· Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies
· Develop and execute systems level and functional area tests
· Monitoring and developing software reliability improvements to existing & new design
· Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities
· Investigate/reproduce customer problems/issues
· Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001
· Develop and implement quality metrics associated with software development and performance.
· Support Software Quality System sub-systems as directed by senior management, i.e. CAPA, Internal Audits, etc…
PHYSICAL DEMANDS AND WORKING CONDITIONS:
• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities
to perform the essential functions.
· Bachelor's Degree in Engineering or Computer Science
· 7+ years related Software Quality Assurance/Quality Engineering experience
· 4+ years experience with embedded software or real-time devices/systems level testing required
· ASQ Certification(s) a plus, Six Sigma experience highly desirable
· Working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required.
· Excellent verbal communication and technical writing skills
· Ability to interface with multiple groups in the organization.
· Experience with structured programming languages and scripting desired
· Software - Computer skills – C++, C, Java and object oriented design, embedded software design and automated testing, data security.
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