Source description
About the role
Extensive knowledge on Software quality in Medical Device Industry (i.e., IEC-62304 and FDA Guidelines) Class II or Class III devices.
Extensive knowledge on SDLC
Extensive knowledge on Reviewing of S/W Testing Lifecycle.
Knowledge of ALM and SCM such as Helix and Surround.
Expertise in Software Documentation and document control.
Expertise of Software Configuration management.
Basic Qualifications
At least 5 Years of Experience as a SW QE participating in code reviews and design reviews
Experience in reviewing software documentation (requirements, design, test plans, test protocols, test reports)
Experience with regression, impact and dependency analysis.
Experience as a software developer for medical devices, or experience in C++ and C# is a plus (embedded software, windows platform software, or both)
Nice to have - Cybersecurity knowledge and Medical Device Risk Management knowledge (ISO-14971).
Experience as a software test engineer or system integration engineer (system test, integration test, unit test) is a plus
Experience performing software quality audits is a plus
Typical tasks
Review all documentation generated by software developers and testers including
Test case initial review / feedback loop for corrections
Software design documents
Requirement updates
Participate in meetings for
Code reviews
Formal test case reviews
Additional documentation for software review / design review
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