Mechanical Risk Engineer - Kardium

Help shape medical technology as a Mechanical Risk Engineer at Kardium in Burnaby, British Columbia. Collaborate with cross-functional teams to enhance product safety and reliability through focused risk management.

As part of the Quality Engineering team, you'll influence mechanical design and manufacturing for the Globe® Pulsed Field System. Key responsibilities include conducting failure analyses and guiding the Mechanical team on risk control strategies. Your analytical skills and attention to detail will ensure compliance with rigorous regulatory standards while contributing to groundbreaking advancements in atrial fibrillation treatment.

Key Responsibilities:

• Perform technical failure analysis for the Kardium Globe® product

• Support Mechanical and Manufacturing teams in investigations

• Conduct impact analysis on manufacturing changes

• Guide Mechanical and Testing teams on risk-based test plans

• Assess quality disposition for non-conformances

Requirements:

• Bachelor's degree in Mechanical or Biomedical Engineering

• 4+ years in a regulated industry, preferably medical devices

• Knowledge of ISO 14971 and risk management tools

• Strong analytical and communication skills

• Excellent mechanical aptitude

Bring your expertise in risk analysis and engineering to Kardium and help transform heart health.
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