Edwards Lifesciences Engineer I Components and Tissue Processing – Irvine Implant Manufacturing (2nd Shift) in Irvine, California
This is an exciting opportunity within our Irvine Implant Manufacturing Plant supporting manufacturing engineering for Components and Tissue processing used to build Surgical, THV and TMTT heart valves. The Engineer 1 will be a key member of a cross-functional core team accountable for all aspects of the Components and Tissue operations value stream (safety, quality, delivery, cost) with support of tasks for sustaining and continuous improvement. In this role, the engineer will support engineering activities from new product introduction, continuous improvement, global process transfers, line sustaining, validation activities and MES support.
2nd Shift Working Hours: 1:30 pm – 10:30 pm .
Essential job functions:
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)
Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes
Oversee manufacturing support tasks; give instruction to technicians, leads or operators on conducting tests; train technicians, leads or operators and provide feedback; and coordinate technician work
Perform other duties and responsibilities as assigned.
- Bachelor's Degree in Engineering or Scientific field.
Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred.
Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills.
Basic understanding of statistical techniques.
Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
Good problem-solving, organizational, analytical and critical thinking skills
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management 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
Ability to manage competing priorities in a fast-paced environment
Ability to build productive internal/external working relationships.
Ability to interact professionally with all organizational levels.
Must be able to work in a team environment.
Adhere to all EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 15,000 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.