- Enhance manufacturing workflows by employing engineering methodologies (such as Six Sigma and Lean principles) to facilitate continuous improvement and/or redesign of equipment, tools, and fixtures.
- Design and conduct moderately complex experiments and tests, including the development and execution of protocols to validate manufacturing processes; analyze findings, provide recommendations, and prepare comprehensive reports.
- Investigate and resolve moderately complex manufacturing and compliance challenges (e.g., CAPA, non-conformances, audit findings).
- Create training and documentation resources (e.g., work instructions) to ensure effective knowledge transfer regarding project and manufacturing processes.
- Establish project timelines to guarantee that deliverables meet customer expectations, utilizing project management tools (e.g., Project Plans, Risk Analysis).
- Supervise manufacturing support activities; instruct technicians on testing procedures; train and provide feedback to technicians; coordinate technician tasks.
- Perform other related duties as assigned by management.
- Bachelor's Degree in Engineering or a related scientific discipline with a minimum of 2 years of relevant experience OR
- Master's Degree or equivalent experience, including internships, senior projects, or thesis work in Engineering.
- Proficient in MS Office Suite, including MS Project; CAD experience is a plus.
- Strong documentation, communication (both written and verbal), and interpersonal skills, including consultative and relationship management abilities.
- Basic knowledge of statistical methods.
- Prior experience with laboratory or industrial equipment is preferred.
- Comprehensive understanding of engineering principles, theories, and concepts.
- Excellent problem-solving, organizational, analytical, and critical thinking capabilities.
- Thorough understanding of processes and equipment relevant to assigned tasks.
- Familiarity with Edwards Environmental Health and Safety and Quality standards as they pertain to clean room medical device manufacturing.
- Knowledge of applicable FDA regulations within the medical device sector.
- Exceptional attention to detail.
- Able to interact professionally with all levels of the organization.
- Capacity to manage competing priorities in a dynamic environment.
- Team-oriented mindset, with the ability to manage vendors and project stakeholders effectively.
- Ability to cultivate productive working relationships internally and externally.
- Commitment to adhering to all company policies and procedures, including safety protocols and environmental guidelines.
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Manufacturing Validation Specialist II - Cartago, Costa Rica - Edwards Lifesciences
Descripción
Join a team dedicated to making a significant impact on patient care globally. At Edwards Lifesciences, our Manufacturing divisions are responsible for developing the tools, technologies, and devices that enhance the lives of patients.
As a vital member of our sewing, assembly, delivery, and distribution teams, your meticulous attention to detail and dedication to ongoing improvement will be essential in transforming innovative concepts into tangible solutions. Your meaningful contributions will create lasting positive effects on patient outcomes.
Key Responsibilities:
Preferred Qualifications:
