Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
**Key Responsibilities**:
- Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement
- Develop basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Analyze and resolve basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
- Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes
- Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
- Other incidental duties assigned by Leadership
**Education and Experience**:
Bachelor's Degree in Engineering or scientific field or equivalent Required
**Additional Skills**:
- Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
- Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment preferred (if applicable)
- Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Good problem-solving, organizational, analytical and critical thinking skills
- Good 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
- 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 immediate supervisor and other team members in the section or group; and may interact with vendors
- Ability to build stable working relationships internally
- 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 Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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