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Tier-1 employer and Hyderabad metro location yield moderate applicant competition despite specialized medical-device requirements.
Specialized implantable medical-device, embedded systems and regulatory skills limit cross-industry transferability.
Explicit 8–12 years, medical-device and regulatory experience create highly rigid screening criteria.
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Lead system integration and technical strategy for complex medical device systems within cross-functional teams to achieve project and quality goals.
Investigate and resolve system issues, conduct and lead verification and validation testing to ensure systems meet user needs and regulatory requirements.
Advance system testing capabilities including automated and hands-on evaluation methods to assess product performance and reliability across diverse use cases.
Bachelor's degree in Engineering discipline required; M.Tech/PhD preferred.
8-12 years of overall work experience with at least 5 years in the medical device industry.
Mandatory knowledge of ISO and Quality System Regulation requirements including experience in regulated environment (e.g., IEC-60601, IEC-62304, ISO-14971, FDA 21CFR820.30).
Software development experience of 2+ years and proficiency in system engineering methodologies required.
Experienced in integrating complex biomedical systems, preferably implantable medical devices or related regulated environments such as defense or aerospace.
Demonstrated ability to translate user needs into formal system requirements and make data-driven decisions on system-level issues.
Proficient in advanced system testing, troubleshooting hardware/firmware, and applying risk analysis (FMEA, hazard analysis) with cross-disciplinary collaboration.