Edwards Lifesciences Director, World Wide Engineering Injection Molding in Irvine, California
The Director of Injection Molding for World Wide Engineering will provide technical and strategic leadership of the global Edwards Injection Molding engineering organization. Develop strategy and lead teams to execute Injection Molding category plans that ensure technical sustainability of quality component supply, at scale, across Edwards Businesses and Networks. This includes establishing Engineering standards and best practices for category areas, developing and/or selecting appropriate technologies and processes, and being responsible for supplier technical evaluation, partner selection, component and technology validation, transfer, and integration, as well as identifying supply risks, mitigations and business impact in concert with cross-functional teams from global Operations and New Product Development sites.
Lead, develop, and attract experienced professionals organized across cross-functional teams focused on advancing Injection Molding category technologies that can manage both current and future business needs.
Provide leadership in the global Technical Category strategy and associated supplier processes and management. Develop a robust and credo-based talent development and succession planning in alignment with functional growth strategies.
Set Engineering standards and best practices for category technology.Oversee the analysis and the resolution of complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
Plan and direct strategic activities including prioritizing and selecting appropriate projectportfolios with overall responsibility for meeting business objectives.Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams. Ensure teams select, scale-up, and implement robust category processes to budget and schedule while maintaining compliance to comprehensive medical device standards.Ensure the appropriate implementation of design for manufacturing, design for cost, mistake proofing, and quality controls to minimize patient and regulatory compliance risks.
Prepare business cases, supporting data, and presentation materials to facilitate strategic decision making and approval of new category technology portfolio strategies with Upper Management.Anticipate financial needs, quantifies budget to support project planning, and manages budget per forecast and schedules.
Establish and apply a global scorecard and performance management process to ensure robust execution of category strategy, projects, and supply chain risk mitigation.Establish program level plans, global scorecards and performance management processes to ensure deliverables are completed in a timely and effective manner.
Perform other duties and responsibilities as assigned.
Education & Experience:
Bachelor's Degree in Engineering: Experience in developing components and processes used in themedical deviceindustry, as well as significant experience in managing associated technical engineering functions required
Extensive experience in hands on implementation and support of medical device technologies within a highly regulated cleanroom manufacturing environment required
Extensive experience in Injection Molding technology development, product requirements development, and Injection Molding manufacturing processes required.
Master's Degree or equivalent : in Engineering, Engineering Management, Technology and/or Business Administration preferred.
Professional Certification and/or State Engineering license preferred.
Proven track record of successfully leading, developing, and mentoring highly educated, skilled engineering teams in a global environment.
Proven ability to evaluate manufacturing processes and automation technologies, and develop a strategy for application of these systems that adds high value to the business.
Demonstrated successful experience in a regulated industry within a manufacturing environment required
Demonstrated, technically sound, engineering leadership background and proven successes in designing and implementing component and processes used in the Biomedical device industry.
Proven success in influencing management strategic decisions to invest in both new and proven technologies and processes.
Extensive experience in utilizing Six Sigma tools to develop new processes and improve existing processes, leading to manufacturing value creation.
Extensive experience in strategic planning and project management.
Excellent documentation and communication skills, interpersonal relationship skills including negotiating and relationship management skills, with ability to drive achievement of objectives.
Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
Expert knowledge and understanding of compliance Regulations that apply to Quality, Regulatory Compliance (21 CFR Part 11), Environmental Health and Safety, as well as have knowledge of standards related to equipment design and implementation into global medical device manufacturing plants.
Technical and managerial leadership enabling process development in global manufacturing sites. Must be able to demonstrate evidence of engaging internal and external engineering resources toward harmonized goals and objectives
Ability to serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
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.