Edwards Lifesciences Staff Quality Engineer in Irvine, California
**RELOCATION NOT BUDGETED (Irvine, CA-based position)
The Staff Quality Engineer role provides support and oversight on commercial class III, implantable devices for Edwards' comprehensive portfolio of treatments for structural heart disease within the Surgical, Transcatheter Heart Valves (THV), and Tricuspid & Mitral Transcatheter Therapies (TMTT) business units. The Staff Engineer will support the Global Supply Chain Network by managing engineering activities from new product introduction, post-production launch, and stabilization. The position will report to the Quality Engineering Manager of RESILIA and work directly with the Managers of Manufacturing Engineering, Operations, and New Product Development/Introduction (NPD/NPI).
Act as a liaison between NPD/NPI, Operations, Quality, Manufacturing, Regulatory, and Planning team members assigned to the project.
Lead in the identification and assist implementation of opportunities to optimize/improve/mistake-proof manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods)
Ensure proper qualification/validation of equipment, tooling, etc.
Accountable for achieving quality metrics during commercialization of new products and process ramp up for production-released products
Drive the development and manage the execution of complex experiments and validations (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
Train, coach, and guide more junior engineers on more complex procedures, processes, and non-conformances
Oversee quality support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback
Lead and establish 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
Other incidental duties
Education and Minimum Requirements:
Bachelor's Degree in Engineering or Scientific field, minimum of 6 years of relevant industry experience required OR
Master's Degree or equivalent in Engineering or Scientific field, minimum of 4 years of relevant industry experience OR
Ph.D. or equivalent in in Engineering or Scientific field, minimum of 2 years of relevant industry experience
- Relevant experience supporting quality engineering for class III medical devices
Additional Talents and General Expectations:
Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
Advanced problem-solving, organizational, analytical and critical thinking skills
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organization
Extensive 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
Proven expertise in usage of MS Office Suite
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
Represents organization in providing solutions to difficult technical issues associated with specific projects
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.