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Mid-level role with moderate employer brand but niche medical-device testing requirements.
Medical-device regulatory and embedded testing expertise makes skills less transferable across industries.
Explicit 4-6 years renal care device experience and mandatory medical standards make filtering strict.
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Accountable for testing and development of safety critical embedded medical devices compliant with IEC62304, ISO13485, ISO14971, IEC 60601 standards.
Responsible for writing and reviewing test protocols and participating in manual and automation testing to ensure on-time quality delivery.
Support external lab testing processes such as TUV and UL certification, utilizing tools like IBM DOORS, RQM, JIRA, and Github.
4-6 years of experience specifically in renal care device testing or related safety critical medical devices.
Experience with embedded medical device software testing lifecycle and standards IEC62304 and IEC 60601.
Proficiency in manual and automation testing methodologies.
Work Experience Required: 4-6 years as stated in JD.
Has deep domain expertise in testing embedded safety critical medical devices within regulated environments such as renal care devices.
Experienced working with medical device regulatory standards and compliance processes including external certification labs.
Operates effectively using formal test management and defect tracking tools in a structured, process-driven development environment.