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Edwards Lifesciences Sr R&D Manager, Engineering - Advanced Technology in Irvine, California

This is an exciting opportunity for an exceptional R&D engineering professional with in-depth experience to join a fast-paced, early product development team in Edwards Lifesciences’ Advanced Technology (AT) Division. AT is dedicated to innovating the future and developing new technologies based on identified needs in Structural Heart Disease to transform treatment and significantly improve patients’ lives.

The Sr. Manager will lead the Implant division of a fast-paced program in the early stages of development. They will provide expertise in the design, optimization, testing, and manufacturing of novel Nitinol implantable medical devices. In addition they will collaborate with internal and external partners to define new opportunities for therapy growth. This is a high visibility and high impact career growth opportunity working on cutting edge therapy development and technology. This position will report into the Director of R&D in AT, and will Manage the Implant Team providing mentorship and development to ensure smooth and continuous operations in engineering.

Key Responsibilities:

  • Initiate and lead in the design, optimization, testing, and manufacturing of implantable medical devices.This includes developing design requirements, generating design concepts and prototypes, pre-clinical evaluations, and manufacturing optimization.

  • 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.

  • Interface with and lead cross-functional teams: Manufacturing, Clinical Affairs, Clinical Engineering, Quality, and Marketing – to ensure compliance with internal and regulatory policies and standards and to develop and provide design recommendations that integrate into complex components or products.

  • Work closely with clinical, engineering, and physician training partners in a pre-clinical and clinical environment with strong knowledge and understanding of cardiovascular anatomy and structural heart disease.

Education and Experience:

Bachelor's Degree in related field and a minimum of 12 years in related experience in engineering or a Master’s Degree and a minimum of 11 years.

Demonstrated track record in management of technical and/or engineering disciplines required and experience working in a regulated industry preferred

Additional Skills:

• Experience in metals, particularly Nitinol, and mechanical design (stent and/or implantable medical device) required and creative design experience using/understanding CREO Parametric (preferred) or SolidWorks for designing test fixtures, manufacturing aids, and implantable medical devices.

• Proven successful project management leadership skills

• Proven expertise in both Microsoft Office Suite and related systems

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

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

• Expert understanding of engineering procedures while identifying applications of functional knowledge and existing methodologies to complex problems

• Expert understanding of related aspects of engineering processes and/or systems

• Knowledge of financial acumen as it relates to engineering

• 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 influence cross-functional partners, business units, and/or sites and may engage with and influence senior management

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

• 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

• Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications

• Lead briefings and technical meetings for internal and external representatives

• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship

• Dedicated to quality client service and pro-active and responsive to client needs.

• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions

• Develop relationships and leverage them to influence change

• Support and solicit input from team members at all levels

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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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