Manufacturing Process Optimization Specialist

hace 1 semana

Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo
About Us
Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, critical care, and surgical monitoring. We collaborate with leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.

Job Description
We are seeking a skilled Manufacturing Engineering II to join our team. As a key member of our manufacturing organization, you will apply your knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. Your primary responsibilities will include:
  • Optimizing 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.
  • Developing moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
  • Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
  • Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
  • Establishing project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).

Requirements
To be successful in this role, you will need:
  • A Bachelor's Degree in Engineering or Scientific field, 2 years experience Required, or Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or education Required.
  • Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
  • Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
  • Brief understanding of statistical techniques.
  • Previous experience working with lab/industrial equipment required (if applicable).
  • 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.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast-paced environment.
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
  • Ability to build productive internal/external working relationships.
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

About Our Company
Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work.

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