Sr. Software Design Quality Engineer

7 days ago

Bengaluru, Karnataka, India Cyient Full time ₹ 15,00,000 - ₹ 25,00,000 per year
  • 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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