SW Quality engineers

• 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