Engineer II, Sustaining THV
Edwards Lifesciences
Edwards Lifesciences seeks an Engineer II to optimize manufacturing processes for cardiovascular medical devices at its Costa Rica facility. The role involves process improvement, experimental validation, compliance issue resolution, and technician supervision within the Global Operations & Quality team.
Responsibilities
- Optimize manufacturing processes using Six Sigma and LEAN methodologies for continuous improvement
- Develop and execute experiments to qualify and validate manufacturing processes; analyze and report results
- Investigate and resolve manufacturing and compliance issues including CAPAs and non-conformances
- Create training materials and work instructions for production technicians
- Establish project plans with deliverables, timelines, and risk analyses for assigned initiatives
Requirements
- Bachelor's degree in engineering or scientific field with 2+ years of experience
- Master's degree with industry or combined industry/education experience acceptable
- Proficiency with MS Office Suite and MS Project; CAD experience preferred
- Knowledge of FDA regulations and medical device manufacturing compliance
- Experience with lab or industrial equipment
- Understanding of statistical techniques and engineering principles
- Strong problem-solving, analytical, and critical thinking abilities
Vacante publicada el 4 días atrás
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