Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Principal Manufacturing Engineer, Pilot Operations – GSC in Irvine, California

This is an exciting opportunity to join the Global Supply Chain (GSC) – Irvine Pilot Operations organization. The Mission of Irvine Pilot Operations is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfers through a strong partnership with the NPD teams and the global plant network.

Essential job functions include:

  • Technical leadership, including evaluation of processes, writing procedures, specification review, product implementation and part transition to manufacturing.

  • Provide DFM assistance and facilitate DFM activities such as 3P events.

  • Work with internal & external R&D/MFG/Quality to identify and implement improvements in design & processes.

  • Consults/coordinates/conducts tooling design, fabrication and validation as needed.

  • Respond with a high sense of urgency to quality issues and escalate / communicate appropriately. Own NCR and CAPA investigations.

  • Perform other duties and responsibilities as assigned.

  • Gather and understand design/process requirements to implement and maintain Manufacturing Execution System (MES) for pilot production lines.

  • Serve as owner of the process FMEA for early stage manufacturing, including conducting walkthroughs/studies and identifying/implementing mitigative actions.

  • Act as point-of-contact for equipment management system (e.g. Maximo) for induction, maintenance, and removal of equipment.

  • Serve as liaison for tooling and equipment validation requirements between manufacturing and NPD/R&D groups.

  • Act as driver for process simplification, including but not limited to manufacturing documentation and tooling/equipment.

  • Perform other duties and responsibilities as assigned.

Qualifications:

  • Bachelor’s degree in engineering.

  • Minimum of 8 years of engineering experience.

Preferred Qualifications:

  • Degree in mechanical or manufacturing engineer is preferred.

  • Master’s degree in engineering is preferred.

  • Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.

  • Understanding of statistical techniques is required. Lean Six Sigma certification is preferred.

  • CAD experience is preferred.

  • Effective communication and project management skills are required.

  • Strong analytical, problem solving, and technical writing skills are preferred.

  • Ability to work well independently based on minimal guidance.

  • Strong interpersonal and intercultural skills are required.

  • Ability to work across various time zones and to travel both domestic and internationally, frequency can vary during the project’s lifecycle (20%-40%).

  • An advanced degree may offset some required experience.

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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