Edwards Lifesciences Principal Engineer, Quality - "Automation" in Irvine, California
The Principal Engineer will have responsibility for quality engineering, quality technical functions and validation strategies in the newly established Advanced Quality Engineering (AQE) group within Corporate Quality of Edwards Lifesciences. The Principal Engineer must be knowledgeable in quality engineering principles, standards and methods to ensure compliance in leading the development of new technologies that will benefit Edwards Global Supply Chain group in the manufacturing arena. The AQE group in partnership with the Worldwide Engineering group is tasked to implement new technologies into manufacturing in areas of automation, inspection, artificial intelligence, and more. The individual will join a highly motivated team developing innovative solutions to improve our capabilities in providing life changing devices to our patients.
Execute corporate objectives working with key stakeholders to define next generation inspection techniques in manufacturing areas.
Drive development and implementation of automated inspection techniques (project initiation to completion) for multiple Edwards sites and business units ensuring validated and collaborated techniques with SPC analysis capabilities. Make recommendations and develop reports while collaborating with team members to drive project completion.
Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering.
Expertise in applying Quality Engineering concepts (e.g., CQE body of knowledge and Six Sigma) with the ability to lead projects utilizing these principles.
Advanced problem-solving, organizational, analytical and critical thinking skills.
Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement.
Initiate, lead, and implement the identification of corporate engineering improvement opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., Six Sigma and LEAN methods) employing technical design skills.
Support labeling, packaging, automation, validation, molding, and AI initiatives currently under the Global Supply Chain Worldwide Engineering group.
Manage and lead projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources from various impacted business units representing quality management on cross-functional teams.
Partner with the Global Supply Chain Worldwide engineering group to identify and implement new technologies that are aligned with future growth, compliance, and product quality.
Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations working in tandem with the Project Management group using appropriate tools (e.g., Project Plan, Risk Analysis, etc.).
Develop training and documentation materials for implementation of new technologies across company to enable the seamless knowledge transfer of project and manufacturing processes.
Develop training and documentation materials for implementation of business approaches to these complex issues across company to enable the seamless knowledge transfer amongst our engineering teams.
Required Qualifications :
Bachelor's Degree in Engineering or Scientific field with minimum of 8 years of experience in engineering, quality, and/or manufacturing; OR Master's Degree in Engineering or Scientific field with minimum of 7 years of experience in engineering, quality, and/or manufacturing
Experience designing and implementing automated systems/solutions for industrial or manufacturing related activities
Preferred Qualifications :
Highly regulated industry experience, preferably medical device, pharma, aerospace, or automotive
Experience with automated inspection vision/camera systems (i.e. Keyence, Cognex, Nikon, SmartScope, etc)
Experience with collaborative robotics or integration of inspection methods into automated manufacturing methods
Complex Mechanical Design and Mechanical Systems Integration experience
Demonstrated experience building, developing, leading, and managing projects within a matrixed organization
Focused on technological innovation; incorporates leading-edge thinking into business; proposes and implements change to support growth and innovation
Solid manufacturing background managing engineers with deep knowledge in systems and automation along with capability to add team oversight in implementation of new technologies
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Demonstrated experience implementing continuous improvement initiatives utilizing Six Sigma/Lean methodologies
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management with ability to drive achievement of objectives
Proven successful project management leadership skills and leading cross-functional project teams
Training and presentation skills required
Strong compliance background
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.