Edwards Lifesciences Principal Facilities Engineer - Irvine Implant in Irvine, California
Helping patients is our life’s work, and your contributions directly impact our ability to transform patient care around the world .” – Michael A. Mussallem, Chairman and CEO
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding Principal Facilities Engineer opportunity in the Facilities & Asset Management organization in our Irvine Implant Manufacturing Plant. The Principal Engineer will lead implementation and sustainability efforts for Factory of the Future with Analytics Intelligence coupled with a practical approach.
Drive the development and manage the execution of highly complex projects and new technologies and innovation (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing equipment processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion.
Integrate operation equipment with controls, automation, and SCADA systems.
Initiate and lead the identification and ensure implementation of opportunities to optimize/improve manufacturing and/or facilities 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, be the change agent .
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, Facilities 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.
Perform other duties and responsibilities as assigned, ability to fill in or support next level responsibility.
Bachelor's Degree in Engineering or Scientific field.
Minimum of 8 years of experience facilities, reliability, and/or engineering.
Medical device, pharma, or biotech cGMP industry experience.
Advanced degree is preferred.
Automation robotics design operations and troubleshooting.
Experienced in Maxmio asset management along with an understanding on reliability.
Strong leadership skills and ability to influence change as a change agent working with small or large groups.
Experience in highly regulated process that are structured in a matrix approach.
Experience in leading contractors, vendors, or suppliers to execute successful assignments.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
Experience with problem solving tools to do root cause analysis in a team approach environment.
Ability to translate complex and technical information to all levels of the organizations.
Ability to interact professionally with all organizational levels along with being flexible to support off shifts as needed for projects or problem resolution.
Ability to manage projects from end to end to fully execute task or projects.
Proven expertise in usage of MS Office Suite; CAD experience preferred.
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.