Edwards Lifesciences Senior MES Engineer in Irvine, California
This is a great Senior Engineer opportunity to lead implementation of Manufacturing Execution System (MES) across multiple product value streams by establishing project plan to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Essential job functions include:
Collaborate with cross functional teams and appropriate stakeholders to translate business/mfg process, ensure proper definition and documentation of system requirements, and provide appropriate solutions through model development and implementation
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) using root cause analysis tools
Develop training and documentation materials (e.g., work instructions) for production and engineering teams to enable the seamless knowledge transfer of project and manufacturing processes
Oversee manufacturing support and system modeling tasks; help provide support and training/development for lower level engineers and technicians on project management methods, system architecture/model development and implementation, conducting tests
Perform other duties and responsibilities as assigned.
- Bachelor's Degree Engineering or Science with 4 years of manufacturing experience in a regulated environment.
Master’s degree is preferred.
Medical device industry experience is preferred.
Experience in implementation and model configuration of Manufacturing Execution system (MES) or Manufacturing Operations Management (MOM), and/or implementation of similar digital enterprise solutions for manufacturing.
Ability to perform queries and complex data analytics, working knowledge of SQL, data science, and analytics
Strong understanding of Organizational Change management methodologies and working knowledge of lean manufacturing foundations and concepts.
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Knowledge of applicable FDA regulations for medical device industry.
Working knowledge of statistical techniques and SPC.
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Strong problem-solving, organizational, analytical and critical thinking skills.
Ability to manage competing priorities in a fast-paced environment.
Proven expertise in usage of MS Office Suite including MS Project and Excel.
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.