Edwards Lifesciences Staff Engineer, Ops Integration - Critical Care (Irvine, CA) in Irvine, California
The dynamic role of Staff Engineer will guide and provide expertise in the optimization of manufacturing processes within the Critical Care GSC operations team.
• Drive the development and manage the execution of highly complex experiments and tests (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
• Initiate and lead the identification 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 on new products and/or processes, etc. are up to standards
• Train, coach, and guide lower level employees on highly complex procedures
• Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Analyze and resolve 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
• May be selected as an Independent Reviewer for design review
• Other incidental duties
Education and Experience:
Bachelor's Degree in Engineering or Scientific field plus a minimum of 6 relative years experience
(or Master's Degree in Engineering or Scientific field plus 5 years relative experience)
Manufacturing engineer experience within regulated industry highly preferred (medical device, biotechnology etc)
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Ability to translate complex and technical information to all levels of the organizations
• Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines
• Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Expert understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• 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
• Represents organization as key technical contact on contracts and projects
• Interacts with senior external representatives on significant technical matters often requiring coordination between organizations
• 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.
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