Edwards Lifesciences Senior Engineering Manager, Process Development – Implant Network in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding leadership opportunity for you to join as the Senior Engineering Manager, Process Development who will lead a multi-disciplinary team of engineers and technologists in the design, development, and implementation of advanced manufacturing process technology for Edwards’ Implant Network. In this role, the Senior Manager will lead the identification, development, validation, and implementation of process technology to achieve operational improvements for legacy processes and introduce advanced manufacturing technologies to assure new product success. This role will apply principles of mechanical design, automation, solutions process design and facilities engineering while incorporating Six Sigma and Lean Manufacturing values to achieve organizational goals. The Senior Engineering Manager will work closely with all Edwards implant manufacturing sites which are Irvine, Singapore, and Costa Rica and across all business units to integrate and harmonize process equipment, processes and associated infrastructure. This role will partner closely with Edwards R&D, Plant Operations leadership, Quality and Regulatory functions to develop strategies and tactics to launch and sustain technology capable to meet future business requirements. The Senior Engineering Manager – Process Development will be responsible for project schedules & budgets and risk management and will periodically report results to the Global Supply Chain Leadership Team. This position reports to the Director of Engineering, Process Development.
Essential job functions include:
Develop & manage advanced process technology strategies, roadmaps and initiatives to improve operational performance and resource efficiency for existing and new products in the Implant Network.
Seek and integrate Voice of Customer & lessons learned input from stakeholders to ensure success.
Conduct business case analysis and employ project management & budgeting practices to assess projects and achieve business objectives.
Lead a multi-disciplinary engineering team to develop, validate and implement technology development projects.
Collaborate with R&D, Quality, Regulatory, and Operations to ensure design efficacy, Operational efficiency and Regulatory compliance.
Employ Six Sigma and Lean Manufacturing principles to enable transformational technologies.
Employ safety, ergonomic and automation principles in the design and implementation of process solutions.
Develop a robust talent development & succession plan in alignment with Implant Network growth strategies.
Travel 15-20% domestic and international.
Perform other duties and responsibilities as assigned.
Bachelor’s degree in engineering or scientific with a combination of process development and leadership experience.
Demonstrated successful track record leading technical and/or engineering staff.
Proven successful project management leadership experience.
Experience working in a regulated industry.
Medical Device industry experience highly desirable.
Demonstrated experience in the application of Six Sigma and Lean Manufacturing principles.
Successful track record developing and managing technical processes in a manufacturing environment.
Demonstrated skill in engineering project, operating budget, and capital expense management.
Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Ability to influence, motivate and inspire employees, stakeholders, and senior management.
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.