Risk Engineer Medical Device Safety

Position: Risk Engineer for Medical Device Safety
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 Biomedical Engineering

• Minimum 4 years of design experience

• At least 3 years in a regulated industry

• Familiar with ISO standards for medical devices

• Strong analytical and communication skills

Your skills will enhance the safety and efficacy of groundbreaking medical devices, directly impacting patient care.
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