Manufacturing Engineer

Qualifications:

• Bachelor’s degree in engineering or related field
• Experience of at least 8 years in medical device manufacturing
• ISO 13485 and FDA environment
• Ability to perform root cause analysis and execute process validations (IQ, OQ, PQ)
• Understanding of statistical analysis (SPC, CPK, DOE)
• Skilled in equipment, tooling, and fixture design, testing, and implementation
• Knowledge of design tools, prototyping techniques, and process evaluation methods
• Strong analytical skills and decision-making ability

Responsibilities:

• Design and validate manufacturing processes, equipment, and fixtures for catheter production
• Troubleshoot production issues and implement improvements for operational efficiency
• Lead projects to enhance production metrics such as uptime, cycle time, and throughput
• Collaborate with vendors to select and develop equipment suitable for manufacturing needs
• Support scale-up efforts from development to commercialization, including process validation and transfer