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The successful candidate will:
Implement the reliability strategy on supported products.
Document all work using Good Documentation Practicesutilizingthe Quality Management System
Work collaboratively with the reliability team to develop and improve the reliability program to improve the success of all products.
engineering teams in reducing warranty claims and improving customer satisfaction by leading reliability efforts on problem identification, root cause analysis, corrective action development, and resolution verification.
Participate in product design and reliability reviews during product development to ensure robustness of product design andsoftware testing processes.
Build andmaintaina software confidence model
Perform DesignFMEAs on allsoftwareand recommend changes to improve product reliability.
Implement Design for Reliability and Design for Six Sigma ideologies.
Provide technical feedback to enhance the on-going quality of products and services.
Ability to meet short- and long-term deadlines.
Effectively meets the needs of internal and external customers.
Ability to function effectively within a dynamic team environment.
Job Knowledge, Skills, Education and Experience Requirements:
Have 5+ years of relevant experience with reliability testing, Design for Reliability, software quality, software testing, and/or software development.
Have aBachelor’s or Master’sDegree (Reliability,ComputerScience, or Biomedical preferred).
Be hands-on and self-motivated.
Have an excellent attitudeanda collaborative spirit.
Be capable of critical thinking, troubleshooting, and problem solving.
Be familiar with Microsoft Suite (Word, Excel, Outlook, Teams, PowerPoint)
Be capable of excelling in a high performing team environment and working with multiple projects simultaneously.
Have experience in an FDA regulated environment.
Be familiar with software tools includingMiniTab,Reliasoft, LabView, Arduino
Certified Reliability Engineer (CRE) Preferred
Strong understanding of medical device industry regulatory requirements including ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.
Six Sigma Green Belt or Black Belt Preferred(or equivalent)
Strong understandingonsoftware quality, software testing,and confidence modelling.
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