Kardium Mechanical Risk Engineering

Position: Kardium Mechanical Risk Engineering Role
Join Kardium as a Mechanical Risk Engineer in Burnaby, BC, and play a vital role in enhancing medical devices through effective risk management techniques. Drive safety and performance in a collaborative environment.

Your position will meld quality engineering and risk assessment in the development of the Globe® Pulsed Field System aimed at treating atrial fibrillation. You will analyze mechanical designs, support critical investigations, and ensure adherence to regulatory benchmarks. This role requires both strong problem-solving capabilities and a keen eye for detail to improve product resilience.

Key Responsibilities:

• Conduct failure analysis of mechanical system designs

• Collaborate with teams on root cause and documentation reviews

• Analyze design changes affecting safety risk profiles

• Develop risk-informed test plans and protocols

• Evaluate quality responses for identified variances

Requirements:

• Bachelor’s in Mechanical Engineering or related field

• At least 4 years' experience in regulated environments

• Familiarity with ISO 14971 and risk management practices

• Excellent technical documentation skills

• Strong analytical abilities and adaptability

Leverage your expertise in risk engineering to support Kardium's life-saving mission.
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