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Tier-1 brand and common QA role increase candidate density moderately.
High because medical device regulatory and system-level hardware-software testing constrain cross-industry transferability.
High due to strict 12–16 years, medical-device regulatory experience, and specified automation/tool requirements.
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Design, develop, and maintain scalable automated testing frameworks for complex medical device software.
Collaborate with cross-functional teams to verify software functionality meets product and regulatory requirements, including medical device standards such as IEC 62304 and FDA guidance.
Manage multiple hardware and software test configurations and perform system-level testing of integrated hardware and software platforms.
Bachelor’s degree in computer science, software engineering, or equivalent.
12 to 16 years of relevant experience, preferably with biomedical expertise.
Strong programming skills in Python, C#, or C++ and experience with UI automation tools like Ranorex, Appium, Katalon, or Squish.
Experience in software verification, validation, regulatory compliance (medical device standards), and Agile/Scrum environments.
Experienced in test automation for regulated medical device software development.
Proficient in software development lifecycle and quality management system processes, with ability to integrate software and hardware testing.
Capable of managing complex test environments and collaborating across software, systems, hardware, and quality engineering teams.