Edwards Lifesciences Director, Global R&D Packaging in Irvine, California
Directs new packaging development engineering teams and provides overall leadership for new product development including the design, development, testing and validation of sterile packaging systems, packaging equipment and manufacturing processes to support clinical trials, limited market releases and commercial product launches
Works across the organization to gain alignment and establish goals and objectives for the team to support the company’s KODs. Focuses on working with BU R&D leadership to define and execute comprehensive packaging design and validation strategies to achieve value optimization.
Ensures that voice-of-customer and clinical usability are addressed in packaging design requirements, regulatory compliance, environmental registration, validation/testing protocols and plans, manufacturability and supply chain activities.
Oversees the effective design transfer to manufacturing, supply chain and logistics to ensure successful release for commercialization.
Provides strategic leadership to the Advanced Packaging Technology team to drive innovation by identifying new materials, processes and technologies to differentiate Edwards’ technical capabilities.
Plans, directs, and prioritizes strategic activities with overall responsibility for meeting business objectives. Leads in identifying risk, developing all mitigation strategies within Packaging Engineering, best practices, alternative solutions and resolving issues in collaboration with cross functional and/or matrix teams.
Drives the development of new and improved systems, processes, methods, equipment and technology in order to position Advanced Technology for growth, technical capability and compliance.
Drives execution and team performance through performance management and the creation of development plans to address career development opportunities.
Directs the annual budget planning and resource management for the R&D packaging engineering organization including NPD Packaging, Advanced Packaging Technology and Packaging Test Lab.
Provides support and appropriate follow-up for regulatory agency audits to ensure compliance.
Builds constructive cross-functional relationships across a matrixed and decentralized organization.
Sustains a motivating, collaborative and trusting environment where all team members experience professional growth and can reach their full potential by creating best practices for the industry.
Qualifications – External
Bachelor of Science Degree in packaging, engineering or a relevant technical field with 15 years experience. Master’s degree in technical or business discipline preferred.
Minimum of 12 years of progressive leadership experience in medical device or a related industry with proven managerial and technical skills leading a team of packaging engineers and/or managers.
Proven record that demonstrates that he/she is adept at creating, directing and implementing plans, defining project management goals and subsequently executing and achieving desired outcomes.
A track record of successfully maintaining and mentoring highly educated, skilled engineers in a dynamic environment in which verifiable achievements, creativity and innovation have been proven.
Proven supervisory and organizational development capability.
Proven ability to consistently generate and implement innovative and unique solutions to complex technical and human resource problems is required.
Successful experience with project management. Proven experience working with quality system tools and professionals to ensure highly reliability processes.
Good communication and interpersonal skills to work effectively with all levels of employees, vendors, industry personnel.
Strong ability to develop resources and influence others. Ability to set strategic direction for organization and broadly communicate the vision, strong results orientation and people development skills are essential.
Strategic thinker with excellent analytical and problem-solving ability, good verbal and writing communication as well as proficient project management and computer skills.
Demonstrated strong business acumen, strategic planning and financial management that has ensured budget (Capex and Opex) attainment.
In-depth knowledge of design control principles as well as new packaging development and validation process for medical device packaging including materials, design, validation testing, equipment and processes, as well as quality systems and global regulatory 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 15,000 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.