Description
Shape the future of healthcare as a Systems Risk Engineer with a focus on software safety and compliance. Embrace a hybrid work model while ensuring the highest safety standards for innovative medical technology.
In this pivotal role on the Quality Engineering team, you will conduct risk management for life-saving medical devices. Your expertise will guarantee that design modifications adhere to rigorous safety benchmarks, accompanied by comprehensive documentation for regulatory submissions. This role plays a crucial part in launching essential heart treatment technologies.
Key Responsibilities:
• Create and maintain design Failure Mode Effects Analysis (FMEA)
• Collaborate to identify safety risks and propose mitigations
• Evaluate design change impacts on safety profiles
• Prepare thorough risk documentation for regulatory approval
• Analyze software vulnerabilities and their implications
Requirements:
• Bachelor’s degree in Software, Electrical or Biomedi...
In this pivotal role on the Quality Engineering team, you will conduct risk management for life-saving medical devices. Your expertise will guarantee that design modifications adhere to rigorous safety benchmarks, accompanied by comprehensive documentation for regulatory submissions. This role plays a crucial part in launching essential heart treatment technologies.
Key Responsibilities:
• Create and maintain design Failure Mode Effects Analysis (FMEA)
• Collaborate to identify safety risks and propose mitigations
• Evaluate design change impacts on safety profiles
• Prepare thorough risk documentation for regulatory approval
• Analyze software vulnerabilities and their implications
Requirements:
• Bachelor’s degree in Software, Electrical or Biomedi...
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