Lead Systems Engineer – Risk
Location
Bangalore, India
Job Type
Full-time
Category
other-general
Posted
June 17, 2026
In this role, you will have the opportunity to:
+ Lead and oversee risk management activities across the full lifecycle of medical diagnostic devices.
+ Ensure that product risks are systematically identified, evaluated, controlled, and monitored in compliance with global regulatory and industry standards.
+ Serve as the subject-matter expert on ISO 14971, partnering closely with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Post-Market Surveillance teams to deliver safe, compliant, high-quality products.
The essential requirements of the job include:
+ A bachelor’s degree in Engineering or Science, along with a mandatory ISO 14971 Risk Management certification from a recognized, accredited organization.
+ 10+ years of hands-on experience in Medtech development, with strong expertise in Risk Management and Systems Engineering.
+ Proven ability to lead and execute end-to-end risk m...
+ Lead and oversee risk management activities across the full lifecycle of medical diagnostic devices.
+ Ensure that product risks are systematically identified, evaluated, controlled, and monitored in compliance with global regulatory and industry standards.
+ Serve as the subject-matter expert on ISO 14971, partnering closely with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Post-Market Surveillance teams to deliver safe, compliant, high-quality products.
The essential requirements of the job include:
+ A bachelor’s degree in Engineering or Science, along with a mandatory ISO 14971 Risk Management certification from a recognized, accredited organization.
+ 10+ years of hands-on experience in Medtech development, with strong expertise in Risk Management and Systems Engineering.
+ Proven ability to lead and execute end-to-end risk m...