Edwards Lifesciences Manufacturing Engineer II – Tissue Operations in Irvine, California
The Engineer II for Tissue Operations provides support and oversight on commercial class III, implantable devices for Edwards' comprehensive portfolio of treatments for structural heart disease within the Surgical (SURG), Transcatheter Heart Valves (THV), Tricuspid & Mitral Transcatheter Therapies (TMTT), and Critical Care (CC) business units. The engineer will be a key member of a cross-functional core team accountable for all aspects of the tissue operations value stream (safety, quality, delivery, cost) and support the Global Supply Chain Network by managing engineering activities from new product introduction, continuous improvement, global process transfers, and line sustaining. The engineer will also be responsible for capital equipment validation and troubleshooting, NCRs, CAPAs, and digital system integration (MES).
Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
Analyze and resolve moderately 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.
Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.
Bachelor's degree in engineering discipline is required.
2 years of experience working in a regulated manufacturing facility.
Degree in Mechanical, Manufacturing, Biomedical, or Chemical Engineering preferred.
Familiarity with technologies and processes related to the assembly and manufacture of heart valves, surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred.
Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Basic understanding of statistical techniques.
Previous experience working with lab/industrial equipment required.
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Solid problem-solving, organizational, analytical and critical thinking skills.
Solid understanding of processes and equipment used in assigned work.
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 the ability to manage vendors and project stakeholders.
Ability to build productive internal/external working relationships.
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.