Balloon Manufacturing Engineer

This position involves testing, analysis, and meticulous documentation to ensure product approval and readiness for production.

Key Responsibilities:

• Develop validation plans and protocols for catheter balloon products.
• Execute design, process, and performance validation activities.
• Perform risk assessments (e.g., FMEA) and implement mitigation strategies. 
• Ensure validation aligns with FDA, ISO, and CE marking requirements.
• Work closely with engineering, design, quality assurance, and manufacturing teams.
• Provide technical expertise during reviews and development phases.
• Generate detailed validation reports and maintain comprehensive records.
• Provide daily technical expertise to ensure smooth balloon production.
• Identify opportunities to optimize balloon manufacturing processes and enhance manufacturability.

Requirements:

• • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
  • 3-5 years in medical device industry, particularly in catheter balloons manufacturing.
  • Strong knowledge of balloon blowing process.
  • Proficiency in testing methodologies and validation tools.
  • Analytical problem-solving with attention to detail.
  • Excellent communication and collaboration abilities.