Edwards Lifesciences Senior External Manufacturing Engineer in Irvine, California
Manage and support our Contract Manufacturing Organization (CMO) partners as an extension of our internal network to consistently and efficiently supply high quality products while enabling innovation by leveraging supplier capabilities.
This role will be a primary technical contact for CMO, liaison with Global Engineering, and support quality initiatives.
Essential job functions:
Support design characterization and specifications at the supplier including process development plan and development of manufacturing process at the supplier.
Conduct supplier assessments including supplier operations strategy (ramp up readiness) and capacity planning, including Scenario Planning and links to Business Continuity Plan.
Continuous improvement at the supplier and ensure all phases of product/process development at the supplier meet program timing/key milestones.
Technical problem solving such as failure and root cause analysis.
Support quality initiatives like PQP, CTQ, and support plans for high severity risks.
ECR/ ECN administrative processes.
Perform other duties and responsibilities as assigned.
Bachlors degree in engineering or scientific with 4 years of engineering experience in development and introduction of new products into supply chain.
Medical device or regulated business industry experience.
Master’s degree, Six Sigma Green Belt, and/or Project Management Certification preferred.
Experience in multiple areas of Supply Chain such as Sourcing, Manufacturing, Planning and/or Distribution.
Experience leading cross functional teams without direct line reporting authority.
Basic understanding of statistical techniques.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Experience in preparing for and presenting project status to executive leadership, including the development and managing of dashboards.
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Strong problem-solving, organizational, analytical and critical thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and ability to influence change.
Knowledge of applicable FDA regulations for medical device industry.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work in a global team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
Proven expertise in usage of MS Office Suite including MS Project.
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.