Edwards Lifesciences Veterans Jobs

Job Information

Edwards Lifesciences Distinguished Engineer, Sterilization Engineering in Irvine, California

Role Purpose:

Strategically lead the GSC efforts regarding sterilization engineering to launch new processes, transfer products and resolve complex sterilization issues for existing products.

Essential Function:

The primary responsibilities include the following:

  • Partner with Microbiology/Quality Labs to deliver sterilization processes for new product or process introductions.

  • Provide product transfer support related to sterilization.

  • Provide root cause/corrective action support for excursions within the sterilization process.

  • Provide support for Regulatory Reviews regarding sterilization.

  • Create/maintain Sterilization Engineering Equipment Standards

  • Creating/Reviewing protocols related to sterilization.

Provides leadership and strategies across for Continuous Improvement of in-house sterilization equipment/processes and consult with external sterilization companies. Drives the development of new and improved systems, processes, methods, equipment and technology in order to position GSC for growth, compliance and efficiency. Provide innovative solutions regarding parametric release

Create a motivating and trusting environment to drive compliance to ISO 11135, 14160, 17665 and 17664. Ensure compliance to FDA, EPA and other Regulatory Body standards.Develop a robust talent development and succession planning in alignment with functional growth strategies across the global Labeling organization

Create a motivating and trusting environment to drive compliance to ISO 11135, 14160, 17665 and 17664. Ensure compliance to FDA, EPA and other Regulatory Body standards.Develop a robust talent development and succession planning in alignment with functional growth strategies across the global Labeling organization

Establish and manage Sterilization Supplier, customer and stakeholder relationships across the organization to ensure successful completion of WW Engineering goals and long term GSC Aspirations

Responsible for reviewing and approving new sterilization equipment/processes (and significant changes). Responsible for reviewing material selection and supporting NPD efforts.

Qualifications:

  • Bachelor’s degree in Microbiology is required.

  • Minimum of 15 years of sterilization engineering experience is required.

  • Proven technical experience in multiple sterilization techniques such as EtO, Gamma, eBeam and Autoclaving processes.

  • Proven experience with material compatibility in regard to sterilization.

  • Program and project management. Proven record that demonstrates that he/she is adept at creating, directing and implementing plans, defining project management goals and subsequently attaining the plan.

  • Proven ability to engage and manage multiple projects including multinational engineering teams. Proven ability to consistently generate and implement innovative and unique solutions to complex technical problems is required.

  • 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.

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.

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