Product Quality Engineer - Disposable Set

OrganOx is seeking a Product Quality Engineer to join their Technical Quality Engineering team. The role involves monitoring product performance, supporting investigations, and contributing to process improvements. The team focuses on maintaining and enhancing the quality of medical devices within the OrganOx Metra system, collaborating with Product Sustaining Engineering and contracted suppliers.

Requirements

• Demonstrable related hands on engineering experience in the medical device industry or equivalent
• Knowledge of medical device sterilization and microbiology (preferred)
• Excellent technical report writing skills
• Strong Root Cause Analysis, Design Of Experiments, and test method development experience
• Experience investigating and resolving SCARS and CAPAs
• Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or equivalent work experience
• Ability to travel 10-20%
• Familiarity with ISO14971 and risk management processes (plus)
• Six Sigma Green Belt or Black Belt Certification (preferred)

Benefits

• competitive compensation
• health insurance
• retirement plans
• opportunities for professional development