Sr. Software Design Quality Engineer

4 weeks ago

Bengaluru India Cyient Full time

Job Description - Define and implement reliability strategies and frameworks for software systems. - Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. - Lead risk management activities including DFMEA, hazard analysis, and traceability. - Design and maintain post-market monitoring and alerting solutions to proactively address issues. - Conduct root cause analysis and drive effective CAPA implementation. - Develop tools and automation for reliability testing and validation. - Ensure system availability through redundancy, failover, and recovery strategies. - Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. - Mentor teams on best practices and foster a culture of continuous improvement. Qualifications - Bachelor's/Master's degree in Mechanical Engineering, Biomedical Engineering, or related field. - 7+ years of experience in software quality, reliability, or medical device development. - Strong knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA regulations. - Hands-on experience with software risk management, verification/validation, and automation tools. - Excellent problem-solving, communication, and collaboration skills.

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