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Edwards Lifesciences Senior Engineering Manager, Accessories, Final Packaging, and RESILIA Processing in Irvine, California

The Senior Manager will be supporting sustaining activities in Accessories, Final Packaging, and RESILIA tissue treatment operations. The Senior Manager will be expected to provide direct, day-to-day oversight of all product and process engineering initiatives and support aligning engineering core teams to standard practices for A3 project planning, CAPA support, training and development, and product transfers that align with business objectives. The leader will also help drive improvements and alignment across the Implant Network and execute on critical new production introduction and transfer activities within the Irvine Implant Manufacturing site.

Essential job functions:

  • Plan and direct complex project activities with large-scale or significant business impact with the accountability for successful completion of all project deliverables to the business and develop project plans and schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups.

  • Manage experienced professionals and/or oversee the work of one or more areas, functionalities, and/or locations and have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.

  • Lead cross-functional and/or departmental groups to develop and provide design recommendations that integrate into complex component(s) or product(s).

  • Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.

  • Perform other duties and responsibilities as assigned.

Qualifications:

  • Bachelor’s degree in engineering or scientific with manufacturing engineering and people management experience, within an FDA regulated manufacturing environment.

Preferred Qualifications:

  • Medical device manufacturing experience is highly preferred.

  • Demonstrated track record in management of production, technical and/or engineering disciplines.

  • Experience managing plant operations including execution of build plans and maintaining adequate line capacity with ability to resolve and prevent diverse and complex issues.

  • Proven successful project management leadership skills.

  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.

  • Strong understanding of engineering procedures and processes while looking beyond existing methodologies and own discipline to define and resolve complex problems.

  • Understanding of Lean Manufacturing principles.

  • Knowledge of financial acumen as it relates to the business.

  • Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.

  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of the team to the business.

  • 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.

  • Proven expertise in both Microsoft Office Suite and manufacturing systems.

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.

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