Position requirements:
Bachelor’s Degree (± 16 years) in Computer science, software engineering, or a closely related discipline Or Master’s degree. Minimum of 5 years of related work experience in quality or related field.
Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.
Project experience in software testing practices, methodologies, and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.
Must have demonstrated written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines.
Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively.
Experience in software testing and verification/validation,
Experience developing automation frameworks and scripts using Selenium, and/or Appium, UFT, etc.
Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl
Experience with software configuration, and issue tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
Experience as team-member in Agile SDLC projects/programs
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes, and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
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