Edwards Lifesciences Engineer II, MES Modeling in Salt Lake City, Utah
The Engineer II will apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
• Lead the efforts to digitize the manufacturing process throughout multiple Edwards sites through cross functional project work, focusing on process efficiency and global quality compliance standards
• Work with stakeholders to ensure continuous expansion of the MES system, as well as supporting concurrent system upgrades that impact the global network
• Develop moderately 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 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.)
• Work seamlessly with cross functional team members within and across other business units
• Be a leader in influencing change by implementing process improvement projects that impact multiple functional areas
Education and Experience:
Bachelor's Degree in Engineering or Scientific field, 2 years of experience required or
Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required
• Experience with manufacturing software such as ERP, MES, PLM systems (System use and software implementation) is preferred.
• Strong problem-solving, organizational, analytical and critical thinking skills
• Experience with business intelligence tools (Business Objects, QlikView, Alteryx) preferred
• Experience with SQL preferred
• Knowledge of other functions that provide regular inputs (i.e., Product Development, Engineering, Quality, Purchasing, Manufacturing, Finance, Human Resources, and Operations) and how they interact with one another
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between the global organization
• 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
• 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
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• 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
• 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 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.