Manufacturing Process Optimization Engineer

hace 14 horas


Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

About Edwards Lifesciences

Edwards Lifesciences is a global leader in medical innovations for structural heart disease, critical care, and surgical monitoring. Our passion is to help patients by collaborating with leading clinicians and researchers to address unmet healthcare needs.

We improve patient outcomes and enhance lives by developing devices that replace or repair diseased heart valves, and creating new technologies that monitor vital signs in the critical care setting.

Key Responsibilities:

  • Optimize manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc.
  • Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
  • Develop training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes
  • Establish project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
  • Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

Requirements:

  • Bachelor's Degree in Engineering or Scientific field, 2 years of experience Required
  • Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required

Additional Skills:

  • Good computer skills in usage of MS Office Suite including MS Project
  • CAD experience preferred
  • Good documentation, communication, and interpersonal relationship skills including consultative and relationship management skills
  • Basic understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical, and critical thinking skills
  • Solid understanding of processes and equipment used in assigned work
  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
  • Knowledge of applicable FDA regulations for medical device industry


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