Edwards Lifesciences Manufacturing Engineer II – Product & Process in Irvine, California
The Manufacturing Engineer for Heart Valve Assembly will support process development and optimization, manufacturing line support, equipment development, tooling, process transfers and new product commercialization initiatives to the Implant Valve Network. The Engineer will also focus on high impact projects that drive continuous improvement in the Irvine Implant Manufacturing facility.
Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
Develop complex protocols and tests (e.g. IQ/OQ/PQ) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
Analyze and resolve moderately 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 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.).
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.
- Bachelor's degree in engineering with 2 years of manufacturing engineering experience.
Degree in Mechanical, Manufacturing, or Biomedical preferred.
Experience in the Medical device industry is preferred.
Experience working in a regulated manufacturing facility preferred.
Demonstrated use of process and design excellence methodologies to optimize processes and Operations Efficiency.
Demonstrated use of Design for Manufacturability, Industrial Engineering and lean experience leading to manufacturing efficiency improvement.
Familiarity with technologies and processes related to the assembly and manufacture of heart valves, surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred.
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.
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.
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.
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 13,000 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.