Systems Risk Engineer

Position: Systems Risk Engineer at Kardium
Join Kardium as a Systems Risk Engineer to enhance software and electrical safety in medical devices. This hybrid position in Burnaby, BC, focuses on conducting risk management activities for innovative heart rhythm solutions.

As part of the Quality Engineering team, you will collaborate with software and electrical engineers to ensure regulatory compliance and product safety.

Your role includes creating FMEA documents, performing impact analyses, and analyzing software risks to uphold rigorous safety standards. Your analytical skills and attention to detail will drive the reliable design of life-saving technologies and improve patient outcomes.

Key Responsibilities:

• Create design and process FMEA documents

• Document safety risks and identify mitigations

• Analyze design changes on safety profiles

• Assess software bugs for impact on device risk

• Collaborate on regulatory submission documentation

Requirements:

• Bachelor’s degree in relevant engineering field

• Minimum 4 years of related experience

• 3 years’ experience in regulated industries

• Knowledge of ISO and IEC medical device standards

• Strong communication and analytical skills

Drive meaningful change in healthcare by ensuring the safety and performance of cutting-edge medical devices at Kardium.
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